FDA 510(k) Application Details - K974638

Device Classification Name	Wrap, Sterilization   More FDA Info for this Device
510(K) Number	K974638
Device Name	Wrap, Sterilization
Applicant	CASE MEDICAL, INC. 1900 K STREET, N.W. WASHINGTON, DC 20006-1108 US Other 510(k) Applications for this Company
Contact	LARRY R PILOT Other 510(k) Applications for this Contact
Regulation Number	880.6850   More FDA Info for this Regulation Number
Classification Product Code	FRG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/10/1997
Decision Date	12/18/1997
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