FDA 510(k) Application Details - K951823

Device Classification Name	Plasma, Coagulation Control   More FDA Info for this Device
510(K) Number	K951823
Device Name	Plasma, Coagulation Control
Applicant	PRECISION BIOLOGICALS, INC. 900 WINDMILL ROAD UNIT 100 DARTMOUTH, NOVA SCOTIA B3B 1P7 CA Other 510(k) Applications for this Company
Contact	STEPHEN L DUFF Other 510(k) Applications for this Contact
Regulation Number	864.5425   More FDA Info for this Regulation Number
Classification Product Code	GGN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/20/1995
Decision Date	01/03/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review