The following data is part of a premarket notification filed by Crossroads Trading Co. with the FDA for Pembush.
Device ID | K942634 |
510k Number | K942634 |
Device Name: | PEMBUSH |
Classification | Toothbrush, Powered |
Applicant | CROSSROADS TRADING CO. 257 CLOYDON CIRCLE Montecito, CA 93108 |
Contact | Douglas A Trigg |
Correspondent | Douglas A Trigg CROSSROADS TRADING CO. 257 CLOYDON CIRCLE Montecito, CA 93108 |
Product Code | JEQ |
CFR Regulation Number | 872.6865 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-06-03 |
Decision Date | 1994-09-02 |