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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cystourethroscope
510(k) Number K061646
Device Name LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIES
Applicant
Laserscope
3070 Orchard Dr.
San Jose,  CA  95134
Applicant Contact PAUL HARDIMAN
Correspondent
Kema Quality B.V.
4377 County Line Rd.
Chalfont,  PA  18914
Correspondent Contact PATRICIA L MURPHY
Regulation Number876.1500
Classification Product Code
FBO  
Date Received06/12/2006
Decision Date 06/27/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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