FDA 510(k) Application Details - K970152

Device Classification Name	Wrap, Sterilization   More FDA Info for this Device
510(K) Number	K970152
Device Name	Wrap, Sterilization
Applicant	MEDCARE MEDICAL GROUP, INC. 234 OLD HOMESTEAD HWY. EAST SWANZEY, NH 03446 US Other 510(k) Applications for this Company
Contact	CRAIG J BELL 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	01/16/1997
Decision Date	03/05/1997
Decision	SN - Substantially Equivalent for Some Indications
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status
Type	Traditional
Reviewed By Third Party	N
Expedited Review