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FDA 510(k) Application Details - K061297
Device Classification Name
Motor, Drill, Pneumatic
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510(K) Number
K061297
Device Name
Motor, Drill, Pneumatic
Applicant
THE ANSPACH EFFORT, INC.
4500 RIVERSIDE DR.
PALM BEACH GARDENS, FL 33410 US
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Contact
JAMES CARBONE
Other 510(k) Applications for this Contact
Regulation Number
882.4370
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Classification Product Code
HBB
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More FDA Info for this Product Code
Date Received
05/09/2006
Decision Date
01/26/2007
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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