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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 K935045
Device Name BIOSEARCH LAPROSCOPIC GASTRONOMY CATHETER
Applicant
BIOSEARCH MEDICAL PRODUCTS, INC.
35 INDUSTRIAL PKWY.
P.O. BOX 1700
SOMERVILLE,  NJ  08876
Applicant Contact MARTIN DYCK
Correspondent
BIOSEARCH MEDICAL PRODUCTS, INC.
35 INDUSTRIAL PKWY.
P.O. BOX 1700
SOMERVILLE,  NJ  08876
Correspondent Contact MARTIN DYCK
Regulation Number876.5980
Classification Product Code
KNT  
Date Received10/21/1993
Decision Date 08/19/1994
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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