The following data is part of a premarket notification filed by Collagen Corp. with the FDA for Osseotite Irrigation Unit.
| Device ID | K901600 |
| 510k Number | K901600 |
| Device Name: | OSSEOTITE IRRIGATION UNIT |
| Classification | Unit, Oral Irrigation |
| Applicant | COLLAGEN CORP. 2500 FABER PLACE Palo Alto, CA 94303 |
| Contact | Roxanne Dubois |
| Correspondent | Roxanne Dubois COLLAGEN CORP. 2500 FABER PLACE Palo Alto, CA 94303 |
| Product Code | EFS |
| CFR Regulation Number | 872.6510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-06 |
| Decision Date | 1990-06-21 |