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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sound, Urethral, Metal Or Plastic
510(k) Number K950633
Device Name CANDELA URETHRAL/BLADDER SOUND
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 Number876.5520
Classification Product Code
FBX  
Date Received02/13/1995
Decision Date 03/06/1995
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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