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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Activated Partial Thromboplastin
510(k) Number K060688
Device Name HEMOSIL SYNTHASIL
Applicant
Instrumentation Laboratory CO
180 Hartwell Rd.
Bedford,  MA  01730
Applicant Contact CAROL MARBLE
Correspondent
Instrumentation Laboratory CO
180 Hartwell Rd.
Bedford,  MA  01730
Correspondent Contact CAROL MARBLE
Regulation Number864.7925
Classification Product Code
GFO  
Date Received03/15/2006
Decision Date 04/13/2006
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
Recalls CDRH Recalls
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