The following data is part of a premarket notification filed by John O. Butler Co. with the FDA for Trav-ler Kit.
Device ID | K943942 |
510k Number | K943942 |
Device Name: | TRAV-LER KIT |
Classification | Toothbrush, Powered |
Applicant | JOHN O. BUTLER CO. 4635 W. FOSTER AVE. Chicago, IL 60630 |
Contact | Scott Koepsel |
Correspondent | Scott Koepsel JOHN O. BUTLER CO. 4635 W. FOSTER AVE. Chicago, IL 60630 |
Product Code | JEQ |
CFR Regulation Number | 872.6865 [🔎] |
Decision | Substantially Equivalent - Kit (SESK) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-08-12 |
Decision Date | 1995-03-08 |