FDA 510(k) Application Details - K982358

Device Classification Name	Unit, Cryosurgical, Accessories   More FDA Info for this Device
510(K) Number	K982358
Device Name	Unit, Cryosurgical, Accessories
Applicant	ORASURE TECHNOLOGIES, INC. 1745 EATON AVE. BETHLEHEM, PA 18018-1799 US Other 510(k) Applications for this Company
Contact	R.SAM NIEDBALA 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	07/06/1998
Decision Date	10/02/1998
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