The following data is part of a premarket notification filed by Jeneric/pentron, Inc. with the FDA for Jeneric/pentron P0wered Toothbrust.
Device ID | K944084 |
510k Number | K944084 |
Device Name: | JENERIC/PENTRON P0WERED TOOTHBRUST |
Classification | Toothbrush, Powered |
Applicant | JENERIC/PENTRON, INC. 1819 SO. MAY STREET, 2F Chicago, IL 60608 |
Contact | Robert W Bauer |
Correspondent | Robert W Bauer JENERIC/PENTRON, INC. 1819 SO. MAY STREET, 2F Chicago, IL 60608 |
Product Code | JEQ |
CFR Regulation Number | 872.6865 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-08-22 |
Decision Date | 1994-12-20 |