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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 K923002
Device Name ENTEROCLYSIS TUBE
Applicant
BIOSEARCH MEDICAL PRODUCTS, INC.
35 INDUSTRIAL PKWY.
P.O. BOX 1700
SOMERVILLE,  NJ  08876
Applicant Contact PETER GORKY
Correspondent
BIOSEARCH MEDICAL PRODUCTS, INC.
35 INDUSTRIAL PKWY.
P.O. BOX 1700
SOMERVILLE,  NJ  08876
Correspondent Contact PETER GORKY
Regulation Number876.5980
Classification Product Code
KNT  
Date Received06/22/1992
Decision Date 06/28/1994
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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