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FDA 510(k) Application Details - K982837
Device Classification Name
Endoscope, Neurological
More FDA Info for this Device
510(K) Number
K982837
Device Name
Endoscope, Neurological
Applicant
KARL STORZ ENDOSCOPY
600 CORPORATE POINTE
CULVER CITY, CA 90230-7600 US
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Contact
KEVIN KENNAN
Other 510(k) Applications for this Contact
Regulation Number
882.1480
More FDA Info for this Regulation Number
Classification Product Code
GWG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/12/1998
Decision Date
11/06/1998
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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