FDA 510(k) Application Details - K011787

Device Classification Name Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

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510(K) Number K011787
Device Name Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Applicant VIDAMED, INC.
46107 LANDING PKWY.
FREMONT, CA 94538 US
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Contact YI CHEN
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Regulation Number 876.4300

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Classification Product Code KNS
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Date Received 06/08/2001
Decision Date 07/06/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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