The following data is part of a premarket notification filed by Dukal Corp. with the FDA for Gauze Sponge.
| Device ID | K936095 |
| 510k Number | K936095 |
| Device Name: | GAUZE SPONGE |
| Classification | Gauze/sponge, Internal |
| Applicant | DUKAL CORP. P.O. BOX 2308 1247 FLORIDA AVENUE Palm Harbor, FL 34682 -2305 |
| Contact | Patrick J Lamb |
| Correspondent | Patrick J Lamb DUKAL CORP. P.O. BOX 2308 1247 FLORIDA AVENUE Palm Harbor, FL 34682 -2305 |
| 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 | 1993-12-22 |
| Decision Date | 1994-02-02 |