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FDA 510(k) Application Details - K070069
Device Classification Name
Electrode, Cutaneous
More FDA Info for this Device
510(K) Number
K070069
Device Name
Electrode, Cutaneous
Applicant
ASPECT MEDICAL SYSTEMS, INC.
1 UPLAND ROAD
NORWOOD, MA 02062 US
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Contact
VIKRAM VERMA
Other 510(k) Applications for this Contact
Regulation Number
882.1320
More FDA Info for this Regulation Number
Classification Product Code
GXY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/08/2007
Decision Date
02/05/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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