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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name console, heart-lung machine, cardiopulmonary bypass
510(k) Number K851614
Device Name CENTRIMED SYSTEM 1 W/24 VOLT BATTERY POWER SUPPLY
Applicant
CENTRIMED CORP.
651 SIXTEENTH AVENUE S.
HOPKINS,  MN  55343
Applicant Contact LLOYD HUBBARD
Correspondent
CENTRIMED CORP.
651 SIXTEENTH AVENUE S.
HOPKINS,  MN  55343
Correspondent Contact LLOYD HUBBARD
Regulation Number870.4220
Classification Product Code
DTQ  
Date Received04/19/1985
Decision Date 06/19/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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