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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
510(k) Number K871686
Device Name GEM-CRIT CHECK
Applicant
Diamond Sensor Systems
1230 Eisenhower Place
Ann Arbor,  MI  48104
Applicant Contact DAVID BARANSKI
Correspondent
Diamond Sensor Systems
1230 Eisenhower Place
Ann Arbor,  MI  48104
Correspondent Contact DAVID BARANSKI
Regulation Number870.4330
Classification Product Code
DRY  
Date Received04/29/1987
Decision Date 06/18/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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