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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, Semi-Constrained, Metal/Polymer, Uncemented
510(k) Number K002141
Device Name ACUMATCH P-SERIES PRESS-FIT PLASMA, ACUMATCH P-SERIES PRESS-FIT, ACUMATCH L-SERIES PRESS-FIT
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 Number888.3360
Classification Product Code
LWJ  
Subsequent Product Code
MEH  
Date Received07/17/2000
Decision Date 08/16/2000
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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