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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 K993678
Device Name THROMBELASTOGRAPH COAGULATION ANALYZER TEG - 5000 SERIES
Applicant
Haemoscope Corp.
7855 Gross Point Rd.
Suite G4
Skokie,  IL  60077
Applicant Contact ELI COHEN
Correspondent
Haemoscope Corp.
7855 Gross Point Rd.
Suite G4
Skokie,  IL  60077
Correspondent Contact ELI COHEN
Regulation Number864.5425
Classification Product Code
JPA  
Date Received11/01/1999
Decision Date 05/05/2000
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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