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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 K833644
Device Name FILTER PURGE LINE EC-FPL SERIES
Applicant
GISH BIOMEDICAL, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
GISH BIOMEDICAL, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number870.4290
Classification Product Code
DTL  
Date Received10/17/1983
Decision Date 12/29/1984
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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