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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 K071764
Device Name REALIZE GASTRIC CALIBRATION TUBE, MODELS GCT180, GCT360
Applicant
Obtech Medical Sarl
4545 Creek Rd.
Blue Ash,  OH  45242
Applicant Contact ELIZABETH MILLER
Correspondent
Obtech Medical Sarl
4545 Creek Rd.
Blue Ash,  OH  45242
Correspondent Contact ELIZABETH MILLER
Regulation Number876.5980
Classification Product Code
KNT  
Date Received06/29/2007
Decision Date 10/24/2007
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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