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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Leak Tester
510(k) Number K123704
Device Name AUTOMATED ENDOSCOPE LEAK TESTER
Applicant
Olympus Medical Systems Corp.
Regulatory Affairs & Quality Assurance
3500 Corporate Pkwy.
Center Valley,  PA  18034
Applicant Contact DAPHNEY GERMAIN-KOLAWOLE
Correspondent
Olympus Medical Systems Corp.
Regulatory Affairs & Quality Assurance
3500 Corporate Pkwy.
Center Valley,  PA  18034
Correspondent Contact DAPHNEY GERMAIN-KOLAWOLE
Regulation Number876.1500
Classification Product Code
PCV  
Date Received12/03/2012
Decision Date 02/04/2013
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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