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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name hysteroscope (and accessories)
510(k) Number K160510
Device Name MAKO 7
Applicant
nVision Medical Corporation
2500 Grant Road, G01
Mountain View,  CA  94040
Applicant Contact Surbhi Sarna
Correspondent
DOMECUS CONSULTING SERVICES LLC
1171 BARROILHET DRIVE
HILLSBROUGH,  CA  94010
Correspondent Contact Cindy Domecus
Regulation Number884.1690
Classification Product Code
HIH  
Date Received02/24/2016
Decision Date 06/09/2016
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
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