The following data is part of a premarket notification filed by Medtrax Industries, Inc. with the FDA for Medtrax Packing Strip.
Device ID | K926207 |
510k Number | K926207 |
Device Name: | MEDTRAX PACKING STRIP |
Classification | Gauze, External (with Drug/biologic/animal Source Material) |
Applicant | MEDTRAX INDUSTRIES, INC. 1372 BENNETT DR. SUITE 156 Longwood, FL 32750 |
Contact | Juan Alana |
Correspondent | Juan Alana MEDTRAX INDUSTRIES, INC. 1372 BENNETT DR. SUITE 156 Longwood, FL 32750 |
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 | 1992-12-09 |
Decision Date | 1993-05-12 |