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FDA 510(k) Application Details - K011429
Device Classification Name
Transducer, Tremor
More FDA Info for this Device
510(K) Number
K011429
Device Name
Transducer, Tremor
Applicant
TELECOM MEDICAL, INC.
10900 LUCKY OAK COURT
CUPERTINO, CA 95014 US
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Contact
THOMAS C WEHMAN
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
05/09/2001
Decision Date
07/13/2001
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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