FDA 510(k) Application Details - K964047

Device Classification Name	Unit, Cryosurgical, Accessories   More FDA Info for this Device
510(K) Number	K964047
Device Name	Unit, Cryosurgical, Accessories
Applicant	BIODERMIS CORP. 3753 HOWARD HUGHES PARKWAY, SUITE #310 LAS VEGAS, NV 89109 US Other 510(k) Applications for this Company
Contact	DENNIS A REPELLA Other 510(k) Applications for this Contact
Regulation Number	878.4350   More FDA Info for this Regulation Number
Classification Product Code	GEH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/09/1996
Decision Date	03/19/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review