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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cystoscope and accessories, flexible/rigid
510(k) Number K003988
Device Name UROSCOPE, ARTES MEDICAL, USA
Applicant
ARTES MEDICAL USA, INC.
4660 LA JOLLA VILLAGE DR.
CENTER 1, SUITE 825
SAN DIEGO,  CA  92122
Applicant Contact WILLIAM KIRKPATRICK
Correspondent
ARTES MEDICAL USA, INC.
4660 LA JOLLA VILLAGE DR.
CENTER 1, SUITE 825
SAN DIEGO,  CA  92122
Correspondent Contact WILLIAM KIRKPATRICK
Regulation Number876.1500
Classification Product Code
FAJ  
Date Received12/26/2000
Decision Date 09/06/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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