The following data is part of a premarket notification filed by Germiphene Corp. with the FDA for Vapophene.
| Device ID | K961289 |
| 510k Number | K961289 |
| Device Name: | VAPOPHENE |
| Classification | Sterilant, Medical Devices |
| Applicant | GERMIPHENE CORP. 1379 COLBORNE ST., EAST Brantford, Ont, CA N3t 5v7 |
| Contact | Peter Wilk |
| Correspondent | Peter Wilk GERMIPHENE CORP. 1379 COLBORNE ST., EAST Brantford, Ont, CA N3t 5v7 |
| Product Code | MED |
| CFR Regulation Number | 880.6885 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-04 |
| Decision Date | 1997-12-04 |