The following data is part of a premarket notification filed by Teledyne Water Pik with the FDA for Water Pik(r).
Device ID | K894015 |
510k Number | K894015 |
Device Name: | WATER PIK(R) |
Classification | Unit, Oral Irrigation |
Applicant | TELEDYNE WATER PIK 1730 EAST PROSPECT RD. Fort Collins, CO 80525 -1310 |
Contact | Donald W Ruehmann |
Correspondent | Donald W Ruehmann TELEDYNE WATER PIK 1730 EAST PROSPECT RD. Fort Collins, CO 80525 -1310 |
Product Code | EFS |
CFR Regulation Number | 872.6510 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-06-06 |
Decision Date | 1989-08-28 |