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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
Applicant
THE ANSPACH EFFORT, INC.
4500 RIVERSIDE DR.
Palm Bch Gdns,  FL  33410
Applicant Contact JEANNETTE G DAILEY
Correspondent
THE ANSPACH EFFORT, INC.
4500 RIVERSIDE DR.
Palm Bch Gdns,  FL  33410
Correspondent Contact JEANNETTE G DAILEY
Regulation Number882.4310
Classification Product Code
HBE  
Date Received11/22/2011
Decision Date 12/16/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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