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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 K080365
Device Name MORCE POWER PLUS AND VARIOCARVE MORCELLATOR
Applicant
NOUVAG AG
Reusswehrstrasse 1
Gebenstorf,  CH CH-5412
Applicant Contact ERICH FORSTER
Correspondent
NOUVAG AG
Reusswehrstrasse 1
Gebenstorf,  CH CH-5412
Correspondent Contact ERICH FORSTER
Regulation Number884.1720
Classification Product Code
HET  
Date Received02/11/2008
Decision Date 06/29/2009
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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