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U.S. FDA Medical Device Surgical Sponge Scale Requirements


FDA Medical Device Definition: A surgical sponge scale is a nonelectrically powered device used to weigh surgical sponges that have been used to absorb blood during surgery so that, by comparison with the known dry weight of the sponges, an estimate may be made of the blood lost by the patient during surgery.

Registrar Corp assists Surgical Sponge Scale companies with:

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