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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name lithotriptor, electro-hydraulic
510(k) Number K885255
Device Name MDL-1 LASERTRIPTER(TM)
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 Number876.4480
Classification Product Code
FFK  
Date Received12/23/1988
Decision Date 06/01/1989
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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