The following data is part of a premarket notification filed by Germiphene Corp. with the FDA for Odyssey I Dental Water Unit.
| Device ID | K964796 |
| 510k Number | K964796 |
| Device Name: | ODYSSEY I DENTAL WATER UNIT |
| Classification | Unit, Operative Dental |
| Applicant | GERMIPHENE CORP. 1379 COLBORNE ST., EAST Brantford, Ont, CA N3t 5v7 |
| Contact | John Husnik |
| Correspondent | John Husnik GERMIPHENE CORP. 1379 COLBORNE ST., EAST Brantford, Ont, CA N3t 5v7 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-29 |
| Decision Date | 1997-05-14 |