FDA 510(k) Application Details - K091511

Device Classification Name Electrode, Electrosurgical, Active, Urological

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510(K) Number K091511
Device Name Electrode, Electrosurgical, Active, Urological
Applicant MODERN MEDICAL EQUIPMENT MFG., LTD.
35 TAI LIN PAI RD.
KWAI CHUNG, HONG KONG CN
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Contact EUGENE YEUNG
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Regulation Number 876.4300

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Classification Product Code FAS
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Date Received 05/22/2009
Decision Date 01/15/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K091511


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