The following data is part of a premarket notification filed by Cornelia Damsky, Inc. with the FDA for 4 X 4' Gauze Pad.
Device ID | K852857 |
510k Number | K852857 |
Device Name: | 4 X 4' GAUZE PAD |
Classification | Gauze/sponge, Internal |
Applicant | CORNELIA DAMSKY, INC. 56 WESTCOTT RD. Stamford, CT 06902 |
Contact | Cornelia Damsky |
Correspondent | Cornelia Damsky CORNELIA DAMSKY, INC. 56 WESTCOTT RD. Stamford, CT 06902 |
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 | 1985-07-05 |
Decision Date | 1985-07-26 |