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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 K891371
Device Name GILSDORF PERCU. ENDO.-PEG & PERCU. FLOURO.-PFG
Applicant
Entech, Inc.
Rte. 22 E.
Lebanon,  NJ  08833
Applicant Contact LAURENCE A POTTER
Correspondent
Entech, Inc.
Rte. 22 E.
Lebanon,  NJ  08833
Correspondent Contact LAURENCE A POTTER
Regulation Number876.5980
Classification Product Code
KNT  
Date Received03/09/1989
Decision Date 08/03/1989
Decision Substantially Equivalent - With Drug (SESD)
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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