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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 K770002
Device Name CONSOLE, MOBILE FOR 3 PUMPS W/MASTS
Applicant
COBE LABORATORIES, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
COBE LABORATORIES, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number870.4220
Classification Product Code
DTQ  
Date Received01/03/1977
Decision Date 03/07/1977
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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