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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name unit, cryosurgical, accessories
510(k) Number K955011
Device Name CANDELA HCS 2000 URETHERAL WARMER CATHETER
Applicant
CANDELA LASER CORP.
555 THIRTEENTH STREET, N.W
WASHINGTON,  DC  20004 -1109
Applicant Contact JONATHAN S KAHAN
Correspondent
CANDELA LASER CORP.
555 THIRTEENTH STREET, N.W
WASHINGTON,  DC  20004 -1109
Correspondent Contact JONATHAN S KAHAN
Regulation Number878.4350
Classification Product Code
GEH  
Subsequent Product Code
FEZ  
Date Received11/01/1995
Decision Date 04/03/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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