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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Detector, Bubble, Cardiopulmonary Bypass
510(k) Number K935977
Device Name SARNS AIR DETECTION SYSTEM
Applicant
3M Health Care, Sarns
6200 Jackson Rd.
Ann Arbor,  MI  48103
Applicant Contact DENISE D SHIMOKOCHI
Correspondent
3M Health Care, Sarns
6200 Jackson Rd.
Ann Arbor,  MI  48103
Correspondent Contact DENISE D SHIMOKOCHI
Regulation Number870.4205
Classification Product Code
KRL  
Date Received12/13/1993
Decision Date 02/04/1994
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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