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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Laparoscopic
510(k) Number K153513
Device Name Insufflator 50L FM134
Applicant
W.O.M. World of Medicine GmbH
Salzufer 8
Berlin,  DE 10587
Applicant Contact Soeren Markworth
Correspondent
Susanne Raab
1480 Cambridge St.
Cambridge,  MA  02139
Correspondent Contact SUSANNE RAAB
Regulation Number884.1730
Classification Product Code
HIF  
Subsequent Product Code
OSV  
Date Received12/07/2015
Decision Date 03/04/2016
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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