The following data is part of a premarket notification filed by Teledyne, Inc. with the FDA for Pik Pocket (irrigating Tip).
| Device ID | K863131 |
| 510k Number | K863131 |
| Device Name: | PIK POCKET (IRRIGATING TIP) |
| Classification | Unit, Oral Irrigation |
| Applicant | TELEDYNE, INC. 1730 EAST PROSPECT ST. Fort Collins, CO 80525 |
| Contact | Donald Ruehmann |
| Correspondent | Donald Ruehmann TELEDYNE, INC. 1730 EAST PROSPECT ST. Fort Collins, CO 80525 |
| Product Code | EFS |
| CFR Regulation Number | 872.6510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-15 |
| Decision Date | 1986-08-26 |