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U.S. FDA Medical Device Bladder Neck Spreader Requirements

FDA Medical Device Definition: A manual gastroenterology-urology surgical instrument and accessories is a device designed to be used for gastroenterological and urological surgical procedures. The device may be nonpowered, hand-held, or hand-manipulated. Manual gastroenterology-urology surgical instruments include the biopsy forceps cover, biopsy tray without biopsy instruments, line clamp, nonpowered rectal probe, nonelectrical clamp, colostomy spur-crushers, locking device for intestinal clamp, needle holder, gastro-urology hook, gastro-urology probe and director, nonself-retaining retractor, laparotomy rings, nonelectrical snare, rectal specula, bladder neck spreader, self-retaining retractor, and scoop.

Registrar Corp assists Bladder Neck Spreader companies with:

  • FDA Bladder Neck Spreader Establishment Registration
  • FDA Bladder Neck Spreader Listing
  • FDA Bladder Neck Spreader Label Requirements and Exceptions
  • FDA Bladder Neck Spreader Import Information
  • FDA Bladder Neck Spreader Detentions (Bladder Neck Spreader Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Bladder Neck Spreader Manufacturers (Bladder Neck Spreader Suppliers)
       - Bladder Neck Spreader Distributors
       - Bladder Neck Spreader Processors
       - Bladder Neck Spreader Repackers
       - Bladder Neck Spreader Relabelers
       - Bladder Neck Spreader Exporters
       - Bladder Neck Spreader Importers
For more information about Bladder Neck Spreader 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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