FDA 510(k) Application Details - K102663

Device Classification Name Resectoscope

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510(K) Number K102663
Device Name Resectoscope
Applicant NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
22134 SHERMAN WAY
CANOGA PARK, CA 91303 US
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Contact GAYLE BUTLER
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Regulation Number 876.1500

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Classification Product Code FJL
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Date Received 09/15/2010
Decision Date 12/30/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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