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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 K781210
Device Name HEAT EXCHANGER, FHX-14
Applicant
Delta Medical Industries
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Delta Medical Industries
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number870.4240
Classification Product Code
DTR  
Date Received07/17/1978
Decision Date 10/10/1978
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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