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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name drills, burrs, trephines & accessories (simple, powered)
510(k) Number K113476
Device Name ANSPACH DISSECTION TOOLS
Original Applicant
THE ANSPACH EFFORT, INC.
4500 riverside dr.
palm bch gdns,  FL  33410
Original Contact jeannette g dailey
Regulation Number882.4310
Classification Product Code
HBE  
Date Received11/22/2011
Decision Date 12/16/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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