The following data is part of a premarket notification filed by Smith & Nephew United, Inc. with the FDA for Intrasite Gel (labeling Revision).
| Device ID | K904411 |
| 510k Number | K904411 |
| Device Name: | INTRASITE GEL (LABELING REVISION) |
| Classification | Bandage, Liquid |
| Applicant | SMITH & NEPHEW UNITED, INC. 11775 STARKLEY RD. P.O.BOX 1970 Largo, FL 34649 -1970 |
| Contact | Jim Irvine |
| Correspondent | Jim Irvine SMITH & NEPHEW UNITED, INC. 11775 STARKLEY RD. P.O.BOX 1970 Largo, FL 34649 -1970 |
| Product Code | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-26 |
| Decision Date | 1990-11-26 |