The following data is part of a premarket notification filed by Bausch & Lomb, Inc. with the FDA for Interjet(tm) Gingival Care Instrument.
| Device ID | K921999 |
| 510k Number | K921999 |
| Device Name: | INTERJET(TM) GINGIVAL CARE INSTRUMENT |
| Classification | Unit, Oral Irrigation |
| Applicant | BAUSCH & LOMB, INC. 5243 ROYAL WOODS PKWY., #100 Tucker, GA 30084 |
| Contact | Stephens |
| Correspondent | Stephens BAUSCH & LOMB, INC. 5243 ROYAL WOODS PKWY., #100 Tucker, GA 30084 |
| Product Code | EFS |
| CFR Regulation Number | 872.6510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-29 |
| Decision Date | 1992-06-03 |