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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, Gynecologic (And Accessories)
510(k) Number K081173
Device Name ENDOSCOPIC CO2 REGULATION UNIT UCR
Applicant
Olympus Medical Systems Corporation
3500 Corporate Pkwy., P.O. Box 610
Center Valley,  PA  18034 -0610
Applicant Contact LAURA STORMS-TYLER
Correspondent
Olympus Medical Systems Corporation
3500 Corporate Pkwy., P.O. Box 610
Center Valley,  PA  18034 -0610
Correspondent Contact LAURA STORMS-TYLER
Regulation Number884.1720
Classification Product Code
HET  
Date Received04/24/2008
Decision Date 12/23/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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