The following data is part of a premarket notification filed by Absorbent Cotton Co., Inc. with the FDA for Steri-clens(tm) Surgical Scrub Sponge.
Device ID | K874741 |
510k Number | K874741 |
Device Name: | STERI-CLENS(TM) SURGICAL SCRUB SPONGE |
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 | 1987-11-23 |
Decision Date | 1987-12-10 |