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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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