FDA 510(k) Application Details - K970992

Device Classification Name	Unit, Cryosurgical, Accessories   More FDA Info for this Device
510(K) Number	K970992
Device Name	Unit, Cryosurgical, Accessories
Applicant	PREMIER DENTAL PRODUCTS CO. 3600 HORIZON DR. P.O. BOX 61574 KING OF PRUSSIA, PA 19406 US Other 510(k) Applications for this Company
Contact	WILLIAM J FREZEL 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	03/19/1997
Decision Date	06/17/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review