The following data is part of a premarket notification filed by Medicon, Inc. with the FDA for Gauze Asorbable.
Device ID | K844702 |
510k Number | K844702 |
Device Name: | GAUZE ASORBABLE |
Classification | Gauze/sponge, Internal |
Applicant | MEDICON, INC. 143 NEW CANAAN AVE. Norwalk, CT 06850 |
Contact | James C Nicholas |
Correspondent | James C Nicholas MEDICON, INC. 143 NEW CANAAN AVE. Norwalk, CT 06850 |
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 | 1984-12-03 |
Decision Date | 1985-04-01 |