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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spatial Imaging For Display Of Endoscope Position
510(k) Number K134026
Device Name ENDOSCOPE POSITION MARKING PROBE,ENDOSCOPE POSITION DETECTING UNIT
Applicant
Olympus Medical Systems Corp.
3500 Corporate Pkwy.
P.O. Box 610
Center Valley,  PA  18034
Applicant Contact DAPHNEY GERMAIN-KOLAWOLE
Correspondent
Olympus Medical Systems Corp.
3500 Corporate Pkwy.
P.O. Box 610
Center Valley,  PA  18034
Correspondent Contact DAPHNEY GERMAIN-KOLAWOLE
Regulation Number876.1500
Classification Product Code
PGU  
Subsequent Product Codes
FDA   FDF  
Date Received12/30/2013
Decision Date 03/07/2014
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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