The following data is part of a premarket notification filed by Simar, Inc. with the FDA for Simar, Inc. Surgical Dressing.
| Device ID | K970020 |
| 510k Number | K970020 |
| Device Name: | SIMAR, INC. SURGICAL DRESSING |
| Classification | Gauze/sponge, Internal |
| Applicant | SIMAR, INC. 6800 LINDBERGH BLVD. Philadelphia, PA 19142 |
| Contact | Fang Xi Mei |
| Correspondent | Fang Xi Mei SIMAR, INC. 6800 LINDBERGH BLVD. Philadelphia, PA 19142 |
| 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 | 1997-01-03 |
| Decision Date | 1997-03-20 |