The following data is part of a premarket notification filed by Avitar, Inc. with the FDA for Hydrasorb Joyce Sponge.
| Device ID | K925841 |
| 510k Number | K925841 |
| Device Name: | HYDRASORB JOYCE SPONGE |
| Classification | Gauze, External (with Drug/biologic/animal Source Material) |
| Applicant | AVITAR, INC. 250 TURNPIKE ST. Canton, MA 02021 |
| Contact | Paul H Patrone |
| Correspondent | Paul H Patrone AVITAR, INC. 250 TURNPIKE ST. Canton, MA 02021 |
| 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 | 1992-11-18 |
| Decision Date | 1993-05-12 |