The following data is part of a premarket notification filed by Windmere Corp. with the FDA for Plak Trac Powered Toothbrush.
| Device ID | K896245 |
| 510k Number | K896245 |
| Device Name: | PLAK TRAC POWERED TOOTHBRUSH |
| Classification | Toothbrush, Powered |
| Applicant | WINDMERE CORP. 5980 MIAMI LADES DR. Miami Lakes, FL 33014 |
| Contact | J Sokolow |
| Correspondent | J Sokolow WINDMERE CORP. 5980 MIAMI LADES DR. Miami Lakes, FL 33014 |
| Product Code | JEQ |
| CFR Regulation Number | 872.6865 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-30 |
| Decision Date | 1990-03-28 |