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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, Wales,  GB CF3 0LT
Applicant Contact DAVID KAY
Correspondent
Gyrus Medical , Ltd.
Fortran Rd., St. Mellons
Cardiff, Wales,  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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