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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 K923474
Device Name LOW PROFILE GASTROMSTOMY DEVICE
Applicant
BIOSEARCH MEDICAL PRODUCTS, INC.
35 INDUSTRIAL PKWY.
P.O. BOX 1700
SOMERVILLE,  NJ  08876
Applicant Contact ROBERT H BEA
Correspondent
BIOSEARCH MEDICAL PRODUCTS, INC.
35 INDUSTRIAL PKWY.
P.O. BOX 1700
SOMERVILLE,  NJ  08876
Correspondent Contact ROBERT H BEA
Regulation Number876.5980
Classification Product Code
KNT  
Date Received07/14/1992
Decision Date 01/05/1993
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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