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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 K861277
Device Name CRITICHEM CONTINUOUS BLOOD GAS MONTITOR, CVGM-1000
Applicant
Critichem, Inc.
49 Sindle Ave.
Little Falls,  NJ  07424
Applicant Contact CHRISTOPHER ACKER
Correspondent
Critichem, Inc.
49 Sindle Ave.
Little Falls,  NJ  07424
Correspondent Contact CHRISTOPHER ACKER
Regulation Number870.4330
Classification Product Code
DRY  
Date Received04/07/1986
Decision Date 06/02/1986
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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