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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suction Control, Intracardiac, Cardiopulmonary Bypass
510(k) Number K760894
Device Name VACUUM RELIEF VALVE
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 Number870.4430
Classification Product Code
DWD  
Date Received10/26/1976
Decision Date 12/09/1976
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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