The following data is part of a premarket notification filed by Smith & Nephew United, Inc. with the FDA for Hypafix Dressing Retention Sheet.
| Device ID | K894254 |
| 510k Number | K894254 |
| Device Name: | HYPAFIX DRESSING RETENTION SHEET |
| Classification | Dressing, Wound, Drug |
| 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 | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-20 |
| Decision Date | 1989-08-31 |