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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
510(k) Number K761021
Device Name ANKLE INSTRUMENTS (FREEMAN-SWANSON)
Applicant
Medishield, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Medishield, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number888.3110
Classification Product Code
HSN  
Date Received11/11/1976
Decision Date 11/23/1976
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
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