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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 K994166
Device Name GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE ELECTRODE
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  
Subsequent Product Code
FDC  
Date Received12/09/1999
Decision Date 12/27/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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