The following data is part of a premarket notification filed by Fred Sammons, Inc. with the FDA for Disposable Tooth Brush.
Device ID | K823626 |
510k Number | K823626 |
Device Name: | DISPOSABLE TOOTH BRUSH |
Classification | Adaptor, Hygiene |
Applicant | FRED SAMMONS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | ILS |
CFR Regulation Number | 890.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-12-06 |
Decision Date | 1982-12-30 |