FDA 510(k) Application Details - K955795

Device Classification Name	Centrifuge, Hematocrit   More FDA Info for this Device
510(K) Number	K955795
Device Name	Centrifuge, Hematocrit
Applicant	NOVONX, INC. 2257 SOUTH 11000 EAST SUITE 1A SALT LAKE CITY, UT 84106 US Other 510(k) Applications for this Company
Contact	GLEN S PUTNAM Other 510(k) Applications for this Contact
Regulation Number	864.6400   More FDA Info for this Regulation Number
Classification Product Code	GKG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/22/1995
Decision Date	03/29/1996
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