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FDA 510(k) Application Details - K133604
Device Classification Name
Motor, Drill, Electric
More FDA Info for this Device
510(K) Number
K133604
Device Name
Motor, Drill, Electric
Applicant
THE ANSPACH EFFORT, INC.
4500 RIVERSIDE DR.
PALM BEACH GARDENS, FL 33410 US
Other 510(k) Applications for this Company
Contact
JEANNETTE G DAILEY
Other 510(k) Applications for this Contact
Regulation Number
882.4360
More FDA Info for this Regulation Number
Classification Product Code
HBC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/25/2013
Decision Date
01/10/2014
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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