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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 K111788
Device Name ENDOEYE HD II
Applicant
Olympus America, Inc.
3500 Corporate Pkwy.
Center Valley,  PA  18034 -0610
Applicant Contact STACY ABBATIELLO KLUESNER
Correspondent
Olympus America, Inc.
3500 Corporate Pkwy.
Center Valley,  PA  18034 -0610
Correspondent Contact STACY ABBATIELLO KLUESNER
Regulation Number884.1720
Classification Product Code
HET  
Date Received06/24/2011
Decision Date 01/13/2012
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
Recalls CDRH Recalls
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