CERVICAL MD, MODEL C10


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

Correspodent Contact rolf wolters
Regulation Number 884.1630
Classification Product Code
HEX  
Date Received 09/24/2007
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