The following data is part of a premarket notification filed by Smith & Nephew United, Inc. with the FDA for Non-absorb Gauze Surg Sponge & Wound Dress/ext Use.
| Device ID | K891460 |
| 510k Number | K891460 |
| Device Name: | NON-ABSORB GAUZE SURG SPONGE & WOUND DRESS/EXT USE |
| Classification | Gauze/sponge, Internal |
| Applicant | SMITH & NEPHEW UNITED, INC. 11775 STARKLEY RD. P.O.BOX 1970 Largo, FL 34649 -1970 |
| Contact | Jim Irvin |
| Correspondent | Jim Irvin SMITH & NEPHEW UNITED, INC. 11775 STARKLEY RD. P.O.BOX 1970 Largo, FL 34649 -1970 |
| Product Code | EFQ |
| 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 | 1989-03-15 |
| Decision Date | 1989-04-17 |