The following data is part of a premarket notification filed by Fraass Survival Systems, Inc. with the FDA for Sponge, Surgical, Gauze, Compressed 2 By 2 Inches.
| Device ID | K864175 |
| 510k Number | K864175 |
| Device Name: | SPONGE, SURGICAL, GAUZE, COMPRESSED 2 BY 2 INCHES |
| 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 (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-24 |
| Decision Date | 1986-11-05 |