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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 K952560
Device Name SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER
Applicant
Sienco, Inc.
557 C Burbank St.
Broomfield,  CO  80020
Applicant Contact JON HENDERSON
Correspondent
Sienco, Inc.
557 C Burbank St.
Broomfield,  CO  80020
Correspondent Contact JON HENDERSON
Regulation Number864.5425
Classification Product Code
JPA  
Date Received06/02/1995
Decision Date 09/05/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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