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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 K971434
Device Name A.M.T. G-TUBE BALLOON REPLACEMENT GASTROSTOMY FEEDING DEVICE
Applicant
APPLIED MEDICAL TECHNOLOGIES
15653 NEO PKWY.
CLEVELAND,  OH  44128 -3150
Applicant Contact THOMAS W PARKINSON
Correspondent
APPLIED MEDICAL TECHNOLOGIES
15653 NEO PKWY.
CLEVELAND,  OH  44128 -3150
Correspondent Contact THOMAS W PARKINSON
Regulation Number876.5980
Classification Product Code
KNT  
Date Received04/18/1997
Decision Date 08/17/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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