FDA 510(k) Application Details - K991321

Device Classification Name	Instrument, Coagulation   More FDA Info for this Device
510(K) Number	K991321
Device Name	Instrument, Coagulation
Applicant	PACIFIC HEMOSTASIS 11515 VANSTORY DR. HUNTERSVILLE, NC 28078-8144 US Other 510(k) Applications for this Company
Contact	LARRY KOPYTA Other 510(k) Applications for this Contact
Regulation Number	864.5400   More FDA Info for this Regulation Number
Classification Product Code	KQG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/19/1999
Decision Date	06/21/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review