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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
Recalls CDRH Recalls
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