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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K950635
Device Name CANDEKA DUKATIR SETS
Applicant
CANDELA LASER CORP.
530 BOSTON POST RD.
WAYLAND,  MA  01778
Applicant Contact THOMAS R VARRICCHIONE
Correspondent
CANDELA LASER CORP.
530 BOSTON POST RD.
WAYLAND,  MA  01778
Correspondent Contact THOMAS R VARRICCHIONE
Regulation Number870.1250
Classification Product Code
DQY  
Subsequent Product Code
GCJ  
Date Received02/13/1995
Decision Date 03/01/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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