The following data is part of a premarket notification filed by Richardson Merrel, Inc. with the FDA for Denture Cleanser & Toothpaste In One.
Device ID | K780254 |
510k Number | K780254 |
Device Name: | DENTURE CLEANSER & TOOTHPASTE IN ONE |
Classification | Cleaner, Denture, Mechanical |
Applicant | RICHARDSON MERREL, INC. 803 N. Front St. Suite 3 McHenry, IL 60050 |
Product Code | JER |
CFR Regulation Number | 872.3530 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-02-16 |
Decision Date | 1978-03-09 |