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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, cannula and tubing, vascular, cardiopulmonary bypass
510(k) Number K771692
Device Name TUBING SETS
Applicant
COBE LABORATORIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
COBE LABORATORIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number870.4210
Classification Product Code
DWF  
Date Received09/06/1977
Decision Date 10/04/1977
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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