FDA 510(k) Application Details - K961289

Device Classification Name	Sterilant, Medical Devices   More FDA Info for this Device
510(K) Number	K961289
Device Name	Sterilant, Medical Devices
Applicant	GERMIPHENE CORP. 1379 COLBORNE ST., EAST BRANTFORD, ONT N3T 5V7 CA Other 510(k) Applications for this Company
Contact	PETER WILK Other 510(k) Applications for this Contact
Regulation Number	880.6885   More FDA Info for this Regulation Number
Classification Product Code	MED Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/04/1996
Decision Date	12/04/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review