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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 K072691
Device Name CERVICAL MD, MODEL C10
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 Received09/24/2007
Decision Date 01/31/2008
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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