The following data is part of a premarket notification filed by Absorbent Cotton Co., Inc. with the FDA for Primaderm.
Device ID | K854740 |
510k Number | K854740 |
Device Name: | PRIMADERM |
Classification | Dressing, Wound, Drug |
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 | FRO |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-11-25 |
Decision Date | 1986-03-14 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PRIMADERM 74166734 1685977 Dead/Cancelled |
Sparta Surgical Corporation 1991-05-15 |
PRIMADERM 73602275 not registered Dead/Abandoned |
ABSORBENT COTTON COMPANY 1986-06-04 |