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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 K130483
Device Name BOEHRINGER GASTRIC SIZING TUBE
Applicant
Boehringer Laboratories, LLC
300 Thoms Dr.
Phoenixville,  PA  19460
Applicant Contact CHRISTOPHER RADL, ENGINEERING
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Regulation Number876.5980
Classification Product Code
KNT  
Date Received02/25/2013
Decision Date 03/28/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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