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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass
510(k) Number K902654
Device Name CDI (TM) SYSTEM 100 MONITORING SYSTEM
Applicant
3M HEALTH CARE, LTD.
2801 BARRANCA RD.
IRVINE,  CA  92714
Applicant Contact JOHN L GEHRICH
Correspondent
3M HEALTH CARE, LTD.
2801 BARRANCA RD.
IRVINE,  CA  92714
Correspondent Contact JOHN L GEHRICH
Regulation Number870.4410
Classification Product Code
DTY  
Subsequent Product Code
DRY  
Date Received06/15/1990
Decision Date 11/05/1990
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
Recalls CDRH Recalls
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