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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 K863642
Device Name CANDELA MODEL MDL-1 LASER LITHOTRIPTOR
Applicant
CANDELA CORP.
19 STRATHMORE RD.
NATICK,  MA  01760
Applicant Contact HORACE FURUMOTO
Correspondent
CANDELA CORP.
19 STRATHMORE RD.
NATICK,  MA  01760
Correspondent Contact HORACE FURUMOTO
Regulation Number876.4480
Classification Product Code
FFK  
Date Received09/17/1986
Decision Date 12/03/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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