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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 K181777
Device Name AggreGuide A-100 ADP
Applicant
Aggredyne, Inc.
10530 Rockely Road, Suite 150
Houston,  TX  77099
Applicant Contact Phillip Speros
Correspondent
Aggredyne, Inc.
10530 Rockely Road, Suite 150
Houston,  TX  77099
Correspondent Contact Phillip Speros
Regulation Number864.5700
Classification Product Code
JOZ  
Date Received07/03/2018
Decision Date 03/29/2019
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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