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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tubes, gastrointestinal (and accessories)
510(k) Number K874755
Device Name EFFNER FE-EX* OROGASTRIC
Applicant
EFFNER AND SPREINE CO.
P.O. BOX 191
PORT WASHINGTON,  NY  11050
Applicant Contact EMMANUEL ANAPLIOTIS
Correspondent
EFFNER AND SPREINE CO.
P.O. BOX 191
PORT WASHINGTON,  NY  11050
Correspondent Contact EMMANUEL ANAPLIOTIS
Regulation Number876.5980
Classification Product Code
KNT  
Date Received11/18/1987
Decision Date 04/06/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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