The following data is part of a premarket notification filed by Fraass Survival Systems, Inc. with the FDA for Frastec Dry Burn Dressing.
| Device ID | K871916 |
| 510k Number | K871916 |
| Device Name: | FRASTEC DRY BURN DRESSING |
| Classification | Gauze/sponge, Internal |
| 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 | EFQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-18 |
| Decision Date | 1987-06-16 |