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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Multipurpose For In Vitro Coagulation Studies
510(k) Number K160502
Device Name TEG 6s Hemostasis System
Applicant
Haemonetics Corporation
400 Wood Rd.
Braintree,  MA  02184
Applicant Contact Paige Sweeney
Correspondent
Haemonetics Corporation
400 Wood Rd.
Braintree,  MA  02184
Correspondent Contact Paige Sweeney
Regulation Number864.5425
Classification Product Code
JPA  
Date Received02/23/2016
Decision Date 04/19/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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