FDA 510(k) Application Details - K050347

Device Classification Name	Unit, Cryosurgical, Accessories   More FDA Info for this Device
510(K) Number	K050347
Device Name	Unit, Cryosurgical, Accessories
Applicant	ENDOCARE, INC. 201 TECHNOLOGY DR. IRVINE, CA 92618 US Other 510(k) Applications for this Company
Contact	EBEN GORDON 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	02/11/2005
Decision Date	02/25/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review