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FDA 510(k) Application Details - K101691
Device Classification Name
Stimulator, Photic, Evoked Response
More FDA Info for this Device
510(K) Number
K101691
Device Name
Stimulator, Photic, Evoked Response
Applicant
LIFELINES LTD.
1468 Harwell Avenue
Crofton, MD 21114 US
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Contact
E. J AMITH
Other 510(k) Applications for this Contact
Regulation Number
882.1890
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Classification Product Code
GWE
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More FDA Info for this Product Code
Date Received
06/16/2010
Decision Date
08/10/2010
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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