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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 K854357
Device Name GEM-6, WITH COMPONENTS
Applicant
Diamond Electro-Tech, Inc.
1230 Eisenhower Place
Ann Arbor,  MI  48104
Applicant Contact STEVEN ENZER
Correspondent
Diamond Electro-Tech, Inc.
1230 Eisenhower Place
Ann Arbor,  MI  48104
Correspondent Contact STEVEN ENZER
Regulation Number870.4330
Classification Product Code
DRY  
Date Received10/29/1985
Decision Date 01/08/1986
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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