The following data is part of a premarket notification filed by Dynarex Corp. with the FDA for Dynarex Gauze Sponge.
| Device ID | K951660 |
| 510k Number | K951660 |
| Device Name: | DYNAREX GAUZE SPONGE |
| Classification | Gauze/sponge, Internal |
| Applicant | DYNAREX CORP. ONE INTERNATIONAL BLVD. Brewster, NY 10509 |
| Contact | John G Moulden |
| Correspondent | John G Moulden DYNAREX CORP. ONE INTERNATIONAL BLVD. Brewster, NY 10509 |
| Product Code | EFQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-10 |
| Decision Date | 1995-05-09 |