The following data is part of a premarket notification filed by Dukal Corp. with the FDA for Dukal Non Adherent Dressing.
| Device ID | K970455 |
| 510k Number | K970455 |
| Device Name: | DUKAL NON ADHERENT DRESSING |
| Classification | Gauze/sponge, Internal |
| Applicant | DUKAL CORP. 40178 U.S. 19 NORTH Tarpon Springs, FL 34689 |
| Contact | Patrick Lamb |
| Correspondent | Patrick Lamb DUKAL CORP. 40178 U.S. 19 NORTH Tarpon Springs, FL 34689 |
| 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 | 1997-02-06 |
| Decision Date | 1997-05-08 |
| Summary: | summary |