The following data is part of a premarket notification filed by Fraass Survival Systems, Inc. with the FDA for Bandage, Gauze (nonabsor. Gauze For External Use).
| Device ID | K870185 |
| 510k Number | K870185 |
| Device Name: | BANDAGE, GAUZE (NONABSOR. GAUZE FOR EXTERNAL USE) |
| Classification | Dressing, Wound, Drug |
| Applicant | FRAASS SURVIVAL SYSTEMS, INC. 3830 BOSTON RD. Bronx, NY 10475 |
| Contact | Patrick A Malia |
| Correspondent | Patrick A Malia FRAASS SURVIVAL SYSTEMS, INC. 3830 BOSTON RD. Bronx, NY 10475 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-16 |
| Decision Date | 1987-02-06 |