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FDA 510(k) Application Details - K102663
Device Classification Name
Resectoscope
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
FJL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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