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FDA 510(k) Application Details - K990522
Device Classification Name
Standard Polysomnograph With Electroencephalograph
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510(K) Number
K990522
Device Name
Standard Polysomnograph With Electroencephalograph
Applicant
LA MONT MEDICAL, INC.
555 D'ONOFRIO DR.
MADISON, WI 53719-2053 US
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Contact
TONY MONTGOMERY
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Regulation Number
882.1400
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Classification Product Code
OLV
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More FDA Info for this Product Code
Date Received
02/18/1999
Decision Date
05/19/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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