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FDA 510(k) Application Details - K010981
Device Classification Name
Device, Vibration Threshold Measurement
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510(K) Number
K010981
Device Name
Device, Vibration Threshold Measurement
Applicant
MEDOC LTD. ADVANCED MEDICAL SYSTEMS
11660 WAYZATA BLVD.
MINNETONKA, MN 55305 US
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Contact
ANN QUINLAN-SMITH
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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
04/02/2001
Decision Date
09/20/2001
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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