FDA 510(k) Application Details - K982151

Device Classification Name	Indicator, Physical/Chemical Sterilization Process   More FDA Info for this Device
510(K) Number	K982151
Device Name	Indicator, Physical/Chemical Sterilization Process
Applicant	CASE MEDICAL, INC. 65 RAILROAD AVE. RIDGEFIELD, NJ 07657-0402 US Other 510(k) Applications for this Company
Contact	MARCIA FRIEZE Other 510(k) Applications for this Contact
Regulation Number	880.2800   More FDA Info for this Regulation Number
Classification Product Code	JOJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/18/1998
Decision Date	02/09/1999
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