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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope Introducer Kit
510(k) Number K933268
Device Name CANDELA GUIDEWIRE
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 Number876.1500
Classification Product Code
NWU  
Subsequent Product Code
OCY  
Date Received07/06/1993
Decision Date 02/10/1994
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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