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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 K090324
Device Name ULTRASIGHT HD DIGITAL COLPOSCOPY WITH IMAGESENSE TECHNOLOGY
Applicant
STI MEDICAL SYSTEMS
733 BISHOP STREET
SUITE 3100
HONOLULU,  HI  96813
Applicant Contact ROLF WOLTERS
Correspondent
STI MEDICAL SYSTEMS
733 BISHOP STREET
SUITE 3100
HONOLULU,  HI  96813
Correspondent Contact ROLF WOLTERS
Regulation Number884.1630
Classification Product Code
HEX  
Date Received02/09/2009
Decision Date 12/20/2010
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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