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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name test, time, prothrombin
510(k) Number K962571
Device Name COAGUCHEK PST SYSTEM
Applicant
BOEHRINGER MANNHEIM CORP.
9115 HAGUE RD.
INDIANAPOLIS,  IN  46250 -0457
Applicant Contact MICHAEL FLIS
Correspondent
BOEHRINGER MANNHEIM CORP.
9115 HAGUE RD.
INDIANAPOLIS,  IN  46250 -0457
Correspondent Contact MICHAEL FLIS
Regulation Number864.7750
Classification Product Code
GJS  
Date Received07/01/1996
Decision Date 04/22/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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