The following data is part of a premarket notification filed by Germiphene Corp. with the FDA for Modification Of: Odyssey I Dental Water Unit.
Device ID | K983847 |
510k Number | K983847 |
Device Name: | MODIFICATION OF: ODYSSEY I DENTAL WATER UNIT |
Classification | Unit, Operative Dental |
Applicant | GERMIPHENE CORP. 1379 COLBORNE ST., EAST Brantford, Ont, CA N3t 5v7 |
Contact | Leslie Drake |
Correspondent | Leslie Drake 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 | 1998-10-30 |
Decision Date | 1998-12-01 |