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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Burr, Orthopedic
510(k) Number K802598
Device Name CARBIDE CUTTING INSTRUMENT/INTRAARTICU
Applicant
THE ANSPACH EFFORT, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
THE ANSPACH EFFORT, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number888.4540
Classification Product Code
HTT  
Date Received10/21/1980
Decision Date 11/19/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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