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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name image, illumination, fiberoptic, for endoscope
510(k) Number K023633
Device Name SOVIS OPTIQUE'S ENDOSCOPIC CABLE
Applicant
SOVIS OPTIQUE
700 THIRTEENTH ST. NW
SUITE 1200
WASHINGTON,  DC  20005
Applicant Contact FRANCES K WU
Correspondent
SOVIS OPTIQUE
700 THIRTEENTH ST. NW
SUITE 1200
WASHINGTON,  DC  20005
Correspondent Contact FRANCES K WU
Regulation Number876.1500
Classification Product Code
FFS  
Date Received10/29/2002
Decision Date 12/31/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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