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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Heat-Exchanger, Cardiopulmonary Bypass
510(k) Number K923311
Device Name CONDUCER HEAT EXCHANGER
Applicant
3M Health Care, Sarns
6200 Jackson Rd.
P.O. Box 1247
Ann Arbor,  MI  48106
Applicant Contact CATHY L SIMPSON
Correspondent
3M Health Care, Sarns
6200 Jackson Rd.
P.O. Box 1247
Ann Arbor,  MI  48106
Correspondent Contact CATHY L SIMPSON
Regulation Number870.4240
Classification Product Code
DTR  
Date Received07/07/1992
Decision Date 09/18/1992
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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