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 |