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FDA 510(k) Application Details - K010270
Device Classification Name
Transducer, Tremor
More FDA Info for this Device
510(K) Number
K010270
Device Name
Transducer, Tremor
Applicant
FLEXABLE SYSTEMS, INC.
16410 E. TOMSTONE AVE.
FOUNTAIN HILLS, AZ 85268-6545 US
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Contact
ROBERT M TRIPP
Other 510(k) Applications for this Contact
Regulation Number
882.1950
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Classification Product Code
GYD
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More FDA Info for this Product Code
Date Received
01/29/2001
Decision Date
07/25/2001
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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