INTRASITE
Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic
SMITH & NEPHEW UNITED, INC.
The following data is part of a premarket notification filed by Smith & Nephew United, Inc. with the FDA for Intrasite.
Pre-market Notification Details
| Device ID | K942748 |
| 510k Number | K942748 |
| Device Name: | INTRASITE |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| 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 | MGQ |
| 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 | 1994-06-10 |
| Decision Date | 1994-06-29 |
Trademark Results [INTRASITE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INTRASITE 73580305 1426221 Live/Registered |
T.J. SMITH AND NEPHEW, LIMITED 1986-01-30 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.