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FDA 510(k) Application Details - K964815
Device Classification Name
Device, Vibration Threshold Measurement
More FDA Info for this Device
510(K) Number
K964815
Device Name
Device, Vibration Threshold Measurement
Applicant
PENTAX PRECISION INSTRUMENT CORP.
3117 COMMERCE PKWY.
MIRAMAR, FL 33025 US
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Contact
PAUL SILVA
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Regulation Number
000.0000
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Classification Product Code
LLN
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More FDA Info for this Product Code
Date Received
11/29/1996
Decision Date
09/04/1997
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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