The following data is part of a premarket notification filed by Smith & Nephew United, Inc. with the FDA for Non-absorbable Gauze, Surgical Sponge & Dressing.
| Device ID | K891101 |
| 510k Number | K891101 |
| Device Name: | NON-ABSORBABLE GAUZE, SURGICAL SPONGE & DRESSING |
| Classification | Gauze, External (with Drug/biologic/animal Source Material) |
| Applicant | SMITH & NEPHEW UNITED, INC. 7172 S. W. 47TH P.O. BOX 55-7638 Miami, FL 33255 |
| Contact | Jim Irvin |
| Correspondent | Jim Irvin SMITH & NEPHEW UNITED, INC. 7172 S. W. 47TH P.O. BOX 55-7638 Miami, FL 33255 |
| Product Code | GER |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-02 |
| Decision Date | 1989-04-17 |