The following data is part of a premarket notification filed by Teledyne Water Pik with the FDA for Pik Pocket(r), Model Pp-3.
| Device ID | K895259 |
| 510k Number | K895259 |
| Device Name: | PIK POCKET(R), MODEL PP-3 |
| 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 | 1989-06-02 |
| Decision Date | 1989-11-01 |