The following data is part of a premarket notification filed by Absorbent Cotton Co., Inc. with the FDA for Plain Dry Gauze.
Device ID | K873523 |
510k Number | K873523 |
Device Name: | PLAIN DRY GAUZE |
Classification | Gauze/sponge, Internal |
Applicant | ABSORBENT COTTON CO., INC. P.O. BOX 268 368 FAIRVIEW AVENUE Hammonton, NJ 08037 |
Contact | Patrick J Lamb |
Correspondent | Patrick J Lamb ABSORBENT COTTON CO., INC. P.O. BOX 268 368 FAIRVIEW AVENUE Hammonton, NJ 08037 |
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 | 1987-09-01 |
Decision Date | 1987-10-09 |