The following data is part of a premarket notification filed by Senair-mot with the FDA for Chew-dent.
Device ID | K843406 |
510k Number | K843406 |
Device Name: | CHEW-DENT |
Classification | Tip, Rubber, Oral Hygiene |
Applicant | SENAIR-MOT 1500 E. KATELLA AVENUE Orange , CA 92667 - |
Contact | Richard G Deniro |
Correspondent | Richard G Deniro SENAIR-MOT 1500 E. KATELLA AVENUE Orange , CA 92667 - |
Product Code | JEW |
CFR Regulation Number | 872.6650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-08-31 |
Decision Date | 1984-12-11 |