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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 K961345
Device Name DOMED PERCUTANEOUS ENDOSCOPIC GASTROSTOMY(P.E.G.) FEEDING TUBE
Applicant
Applied Medical Technologies
6100 W. Creek Rd.
Suite 25
Independence,  OH  44131
Applicant Contact KATHY FELTRIN
Correspondent
Applied Medical Technologies
6100 W. Creek Rd.
Suite 25
Independence,  OH  44131
Correspondent Contact KATHY FELTRIN
Regulation Number876.5980
Classification Product Code
KNT  
Date Received04/08/1996
Decision Date 09/17/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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