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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name adaptor, stopcock, manifold, fitting, cardiopulmonary bypass
510(k) Number K833322
Device Name TUBING CONNECTORS EC-2XXX SERIES
Applicant
GISH BIOMEDICAL, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
GISH BIOMEDICAL, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number870.4290
Classification Product Code
DTL  
Date Received09/26/1983
Decision Date 12/16/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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