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FDA 510(k) Application Details - K020507
Device Classification Name
Endoscope, Neurological
More FDA Info for this Device
510(K) Number
K020507
Device Name
Endoscope, Neurological
Applicant
OLYMPUS WINTER & IBE GMBH
TWO CORPORATE CENTER DR.
MELVILLE, NY 11747-3157 US
Other 510(k) Applications for this Company
Contact
LAURA STORMS-TYLER
Other 510(k) Applications for this Contact
Regulation Number
882.1480
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Classification Product Code
GWG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/15/2002
Decision Date
10/08/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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