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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 K190744
Device Name ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A)
Applicant
Olympus Winter & Ibe GmbH
Kuehnstr. 61
Hamburg,  DE 22045
Applicant Contact Jan-Oliver Upmeier
Correspondent
Olympus Corporation of the Americas
3500 Corporate Parkway
Center Valley,  PA  18034 -061
Correspondent Contact Sheri L Musgnung
Regulation Number884.1720
Classification Product Code
HET  
Subsequent Product Codes
GCJ   NWB  
Date Received03/22/2019
Decision Date 08/29/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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