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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
510(k) Number K010081
Device Name ACUMATCH L-SERIES UNIPOLAR ENDOPROSTHESIS
Applicant
Exactech, Inc.
2320 NW 66th Ct.
Gainesville,  FL  32653
Applicant Contact Lisa Simpson
Correspondent
Exactech, Inc.
2320 NW 66th Ct.
Gainesville,  FL  32653
Correspondent Contact Lisa Simpson
Regulation Number888.3390
Classification Product Code
KWY  
Date Received01/10/2001
Decision Date 02/05/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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