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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dislodger, stone, basket, ureteral, metal
510(k) Number K884738
Device Name CANDELA STONE BASKETS
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 Number876.4680
Classification Product Code
FFL  
Date Received11/14/1988
Decision Date 02/09/1989
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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