The following data is part of a premarket notification filed by Avitar, Inc. with the FDA for Hydrasorb Sterile Dressing.
Device ID | K973260 |
510k Number | K973260 |
Device Name: | HYDRASORB STERILE DRESSING |
Classification | Dressing, Wound And Burn, Occlusive |
Applicant | AVITAR, INC. 65 DAN RD. Canton, MA 02021 |
Contact | Paul H Patrone |
Correspondent | Paul H Patrone AVITAR, INC. 65 DAN RD. Canton, MA 02021 |
Product Code | MGP |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-08-29 |
Decision Date | 1997-10-21 |
Summary: | summary |