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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 K163320
Device Name LAP-Pump PP110
Applicant
W.O.M. WORLD OF MEDICINE GMBH
SALZUFER 8
Berlin,  DE 10587
Applicant Contact Soeren Markworth
Correspondent
W.O.M. WORLD OF MEDICINE GMBH
SALZUFER 8
Berlin,  DE 10587
Correspondent Contact Soeren Markworth
Regulation Number884.1720
Classification Product Code
HET  
Date Received11/23/2016
Decision Date 03/21/2017
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
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