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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Access Overtube, Gastroenterology-Urology
510(k) Number K092156
Device Name CAD 12, COLONOSCOPY ASSIST DEVICE
Applicant
Softscope Medical Technologies, Inc.
4486 Timberline Ct.
St. Paul,  MN  55127
Applicant Contact BERNARD HORWATH
Correspondent
Softscope Medical Technologies, Inc.
4486 Timberline Ct.
St. Paul,  MN  55127
Correspondent Contact BERNARD HORWATH
Regulation Number876.1500
Classification Product Code
FED  
Date Received07/16/2009
Decision Date 10/14/2009
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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