The following data is part of a premarket notification filed by Laboratoires Urgo S.a. with the FDA for Algoplaque Film Extra Thin Hydrocolloid Dressing.
| Device ID | K974348 |
| 510k Number | K974348 |
| Device Name: | ALGOPLAQUE FILM EXTRA THIN HYDROCOLLOID DRESSING |
| Classification | Dressing, Wound And Burn, Occlusive |
| Applicant | LABORATOIRES URGO S.A. 7527 WESTMORELAND AVE. St. Louis, MO 63105 |
| Contact | Evan Dick |
| Correspondent | Evan Dick LABORATOIRES URGO S.A. 7527 WESTMORELAND AVE. St. Louis, MO 63105 |
| Product Code | MGP |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-19 |
| Decision Date | 1998-02-13 |
| Summary: | summary |