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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reservoir, Blood, Cardiopulmonary Bypass
510(k) Number K883345
Device Name SARNS INFANT VENOUS RESERVOIR MODEL #16387
Applicant
3M Health Care, Sarns
6200 Jackson Rd.
Ann Arbor,  MI  48103
Applicant Contact DENISE SHIMOKOCHI
Correspondent
3M Health Care, Sarns
6200 Jackson Rd.
Ann Arbor,  MI  48103
Correspondent Contact DENISE SHIMOKOCHI
Regulation Number870.4400
Classification Product Code
DTN  
Date Received08/09/1988
Decision Date 09/28/1988
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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