The following data is part of a premarket notification filed by Hoyt Laboratories with the FDA for Periodontic Toothbrush, #0126-0190-00.
Device ID | K771185 |
510k Number | K771185 |
Device Name: | PERIODONTIC TOOTHBRUSH, #0126-0190-00 |
Classification | Toothbrush, Manual |
Applicant | HOYT LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EFW |
CFR Regulation Number | 872.6855 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-06-29 |
Decision Date | 1977-07-15 |