The following data is part of a premarket notification filed by Dexide, Inc. with the FDA for Disposable Scrub Brush.
Device ID | K810655 |
510k Number | K810655 |
Device Name: | DISPOSABLE SCRUB BRUSH |
Classification | Gauze, External (with Drug/biologic/animal Source Material) |
Applicant | DEXIDE, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | GER |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-03-03 |
Decision Date | 1981-05-05 |