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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 K973893
Device Name AMT BALLOON STOMA MEASURING DEVICES, AMT BALLOON MEASURING DEVICE, AMT BALLOON MEASURING DEVICE WITH STOP VALVE, AMY BAE
Applicant
Applied Medical Technologies
15653 Neo Pkwy.
Cleveland,  OH  44128
Applicant Contact THOMAS W PARKINSON
Correspondent
Applied Medical Technologies
15653 Neo Pkwy.
Cleveland,  OH  44128
Correspondent Contact THOMAS W PARKINSON
Regulation Number876.5980
Classification Product Code
KNT  
Date Received10/14/1997
Decision Date 12/19/1997
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
Predetermined Change
Control Plan Authorized		 No
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