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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Defoamer, Cardiopulmonary Bypass
510(k) Number K941654
Device Name SARNS FILTERED VENOUS RESERVIOR MODIFICATION
Applicant
3M Health Care, Sarns
6200 Jackson Rd.
Ann Arbor,  MI  48103
Applicant Contact JOHN W TOIGO
Correspondent
3M Health Care, Sarns
6200 Jackson Rd.
Ann Arbor,  MI  48103
Correspondent Contact JOHN W TOIGO
Regulation Number870.4230
Classification Product Code
DTP  
Date Received04/05/1994
Decision Date 07/26/1994
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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