The following data is part of a premarket notification filed by Bausch & Lomb, Inc. with the FDA for Interplak Home Plaque Removal Instrument.
| Device ID | K935561 |
| 510k Number | K935561 |
| Device Name: | INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT |
| Classification | Toothbrush, Powered |
| Applicant | BAUSCH & LOMB, INC. 5243 ROYAL WOODS PKWY., #100 Tucker, GA 30084 |
| Contact | Sydney Lilly |
| Correspondent | Sydney Lilly BAUSCH & LOMB, INC. 5243 ROYAL WOODS PKWY., #100 Tucker, GA 30084 |
| Product Code | JEQ |
| CFR Regulation Number | 872.6865 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-17 |
| Decision Date | 1994-01-26 |