FDA 510(k) Application Details - K073555

Device Classification Name	Adaptor, Holder, Syringe   More FDA Info for this Device
510(K) Number	K073555
Device Name	Adaptor, Holder, Syringe
Applicant	MEDICOOL, INC. 20460 GRAMERCY PL. TORRANCE, CA 90501 US Other 510(k) Applications for this Company
Contact	EUGENE CHANG Other 510(k) Applications for this Contact
Regulation Number	890.5050   More FDA Info for this Regulation Number
Classification Product Code	IQG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/18/2007
Decision Date	07/11/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review