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FDA 510(k) Application Details - K050098
Device Classification Name
Nystagmograph
More FDA Info for this Device
510(K) Number
K050098
Device Name
Nystagmograph
Applicant
DDAT(UK) LTD
91 CLIDDESDEN ROAD
BASINGSTOKE, HAMPSHIRE RG21 3EY GB
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Contact
PETER LIOYD
Other 510(k) Applications for this Contact
Regulation Number
882.1460
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Classification Product Code
GWN
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More FDA Info for this Product Code
Date Received
01/18/2005
Decision Date
05/23/2005
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
Y
Expedited Review
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