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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stents, Drains And Dilators For The Biliary Ducts
510(k) Number K851242
Device Name GRECO-HARVEY SURFACTANT BONDED CATHETER FOR GASTRO
Applicant
Cook, Inc.
Univ. Of Medicine & Dentistry
Of Nj Rutgers Medical School
New Brunswick,  NJ  08903
Correspondent
Cook, Inc.
Univ. Of Medicine & Dentistry
Of Nj Rutgers Medical School
New Brunswick,  NJ  08903
Regulation Number876.5010
Classification Product Code
FGE  
Date Received02/26/1985
Decision Date 09/11/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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