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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colposcope (And Colpomicroscope)
510(k) Number K110147
Device Name ULTRASIGHTHD C31 WITH IMAGESENSE AND REMOTE VIEWER TELEMEDICINE
Applicant
Sti Medical Systems, LLC
4275 Executive Square,
Suite 825
La Jolla,  CA  92037
Applicant Contact ROLF WOLTERS
Correspondent
Sti Medical Systems, LLC
4275 Executive Square,
Suite 825
La Jolla,  CA  92037
Correspondent Contact ROLF WOLTERS
Regulation Number884.1630
Classification Product Code
HEX  
Date Received01/18/2011
Decision Date 04/08/2011
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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