The following data is part of a premarket notification filed by Fraass Survival Systems, Inc. with the FDA for Frastec Drynet, Bridal Veil, Various Sizes.
| Device ID | K912022 |
| 510k Number | K912022 |
| Device Name: | FRASTEC DRYNET, BRIDAL VEIL, VARIOUS SIZES |
| Classification | Gauze, External (with Drug/biologic/animal Source Material) |
| Applicant | FRAASS SURVIVAL SYSTEMS, INC. 3830 BOSTON RD. Bronx, NY 10475 |
| Contact | Colin Offenhartz |
| Correspondent | Colin Offenhartz FRAASS SURVIVAL SYSTEMS, INC. 3830 BOSTON RD. Bronx, NY 10475 |
| 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 | 1991-05-07 |
| Decision Date | 1991-08-02 |