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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Tendon, Passive
510(k) Number K000019
Device Name SINGLE SIZE TENDON SPACER
Applicant
Medist International
9160 Highway 64
Suite 12
Lakeland,  TN  38002
Applicant Contact BERNARD F GRISONI
Correspondent
Medist International
9160 Highway 64
Suite 12
Lakeland,  TN  38002
Correspondent Contact BERNARD F GRISONI
Regulation Number888.3025
Classification Product Code
HXA  
Date Received01/04/2000
Decision Date 03/29/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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