FDA 510(k) Application Details - K163274

Device Classification Name	System, Automated Platelet Aggregation   More FDA Info for this Device
510(K) Number	K163274
Device Name	System, Automated Platelet Aggregation
Applicant	Aggredyne, Inc. 10530 Rockley Road, Suite 150 Houston, TX 77099 US Other 510(k) Applications for this Company
Contact	Philip C. Speros Other 510(k) Applications for this Contact
Regulation Number	864.5700   More FDA Info for this Regulation Number
Classification Product Code	JOZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/21/2016
Decision Date	04/05/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
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