The following data is part of a premarket notification filed by Gam Industries, Inc. with the FDA for Multi-trauma Dressing.
Device ID | K925590 |
510k Number | K925590 |
Device Name: | MULTI-TRAUMA DRESSING |
Classification | Gauze, External (with Drug/biologic/animal Source Material) |
Applicant | GAM INDUSTRIES, INC. P.O. BOX 2226 Petersburg, VA 23804 -1526 |
Contact | Gary J Beden |
Correspondent | Gary J Beden GAM INDUSTRIES, INC. P.O. BOX 2226 Petersburg, VA 23804 -1526 |
Product Code | GER |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-11-05 |
Decision Date | 1993-04-08 |