The following data is part of a premarket notification filed by Teledyne Water Pik with the FDA for Water Pik Sensonic Plaque Removal Instrument.
Device ID | K940288 |
510k Number | K940288 |
Device Name: | WATER PIK SENSONIC PLAQUE REMOVAL INSTRUMENT |
Classification | Toothbrush, Powered |
Applicant | TELEDYNE WATER PIK 1730 EAST PROSPECT RD. Fort Collins, CO 80525 -1310 |
Contact | Cody Riley |
Correspondent | Cody Riley TELEDYNE WATER PIK 1730 EAST PROSPECT RD. Fort Collins, CO 80525 -1310 |
Product Code | JEQ |
CFR Regulation Number | 872.6865 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-01-21 |
Decision Date | 1994-05-26 |