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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name unit, electrosurgical, endoscopic (with or without accessories)
510(k) Number K003569
Device Name PLASMAKINETIC ENDOUROLOGY SYSTEM
Applicant
GYRUS MEDICAL LTD.
FORTRAN RD., ST. MELLONS
CARDIFF,  GB CF3 0LT
Applicant Contact DAVID KAY
Correspondent
GYRUS MEDICAL LTD.
FORTRAN RD., ST. MELLONS
CARDIFF,  GB CF3 0LT
Correspondent Contact DAVID KAY
Regulation Number876.4300
Classification Product Code
KNS  
Date Received11/20/2000
Decision Date 12/19/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Special
Reviewed by Third Party No
Combination Product No
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