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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ureteroscope and accessories, flexible/rigid
510(k) Number K884153
Device Name CANDELA MINIFLEX DEFLECTABLE URETEROSCOPE
Applicant
CANDELA LASER CORP.
530 BOSTON POST RD.
WAYLAND,  MA  01778
Applicant Contact GEORGE CHO
Correspondent
CANDELA LASER CORP.
530 BOSTON POST RD.
WAYLAND,  MA  01778
Correspondent Contact GEORGE CHO
Regulation Number876.1500
Classification Product Code
FGB  
Date Received09/30/1988
Decision Date 12/28/1988
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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