The following data is part of a premarket notification filed by Absorbent Cotton Co., Inc. with the FDA for Steri-clens.
Device ID | K875129 |
510k Number | K875129 |
Device Name: | STERI-CLENS |
Classification | Brush, Scrub, Operating-room |
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 | GEC |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-12-15 |
Decision Date | 1988-02-18 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
STERI-CLENS 85511691 4219562 Dead/Cancelled |
TRE Imports, LLC 2012-01-09 |
STERI-CLENS 73679283 1556464 Dead/Cancelled |
STERILE PRODUCTS CORP. 1987-08-19 |