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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 K151275
Device Name MAKO Device
Applicant
Nvision Medical
250 King St., #676
San Francisco,  CA  94107
Applicant Contact Surbhi Sarna
Correspondent
Domecus Consulting Services, LLC
1171 Barroilhet Dr.
Hillsborough,  CA  94010
Correspondent Contact Cindy Domecus
Regulation Number884.1690
Classification Product Code
HIH  
Date Received05/13/2015
Decision Date 11/13/2015
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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