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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oxygenator, Cardiopulmonary Bypass
510(k) Number K912078
Device Name SARNS SM03 MEMBRANE OXYGENATOR, MODIFICATION
Applicant
3M Health Care, Sarns
6200 Jackson Rd.
Ann Arbor,  MI  48103
Applicant Contact CATHY L SIMPSON
Correspondent
3M Health Care, Sarns
6200 Jackson Rd.
Ann Arbor,  MI  48103
Correspondent Contact CATHY L SIMPSON
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received05/10/1991
Decision Date 08/20/1991
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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