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U.S. FDA Medical Device Surgical Skin Graft Expander Requirements


FDA Medical Device Definition: A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.

Registrar Corp assists Surgical Skin Graft Expander companies with:

  • FDA Surgical Skin Graft Expander Establishment Registration
  • FDA Surgical Skin Graft Expander Listing
  • FDA Surgical Skin Graft Expander Label Requirements and Exceptions
  • FDA Surgical Skin Graft Expander Import Information
  • FDA Surgical Skin Graft Expander Detentions (Surgical Skin Graft Expander Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Surgical Skin Graft Expander Manufacturers (Surgical Skin Graft Expander Suppliers)
       - Surgical Skin Graft Expander Distributors
       - Surgical Skin Graft Expander Processors
       - Surgical Skin Graft Expander Repackers
       - Surgical Skin Graft Expander Relabelers
       - Surgical Skin Graft Expander Exporters
       - Surgical Skin Graft Expander Importers
For more information about Surgical Skin Graft Expander Medical Devices, simply click below:






 
U.S. FDA Regulations:

U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.


Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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