The following data is part of a premarket notification filed by Colgate-palmolive Co. with the FDA for Periogard(r) Periopen.
| Device ID | K901955 |
| 510k Number | K901955 |
| Device Name: | PERIOGARD(R) PERIOPEN |
| Classification | Unit, Oral Irrigation |
| Applicant | COLGATE-PALMOLIVE CO. 909 RIVER RD. Piscataway, NJ 08855 |
| Contact | Craig E Hammes |
| Correspondent | Craig E Hammes COLGATE-PALMOLIVE CO. 909 RIVER RD. Piscataway, NJ 08855 |
| Product Code | EFS |
| CFR Regulation Number | 872.6510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-01 |
| Decision Date | 1991-04-15 |