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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Automated Platelet Aggregation
510(k) Number K122162
Device Name AGGREGUIDE
Applicant
AGGREDYNE, INC.
11874 SOUTH EVELYN CIRCLE
HOUSTON,  TX  77071
Applicant Contact J. HARBEY KNAUSS
Correspondent
AGGREDYNE, INC.
11874 SOUTH EVELYN CIRCLE
HOUSTON,  TX  77071
Correspondent Contact J. HARBEY KNAUSS
Regulation Number864.5700
Classification Product Code
JOZ  
Date Received07/20/2012
Decision Date 12/20/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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