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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 K062383
Device Name UNISYN HA PLASMA MODULAR HIP
Applicant
Hayes Medical, Inc.
1115 Windfield Way, Suite 100
El Dorado Hills,  CA  95762
Applicant Contact LUKE ROSE
Correspondent
Hayes Medical, Inc.
1115 Windfield Way, Suite 100
El Dorado Hills,  CA  95762
Correspondent Contact LUKE ROSE
Regulation Number888.3360
Classification Product Code
LWJ  
Subsequent Product Codes
JDI   LZO   MEH  
Date Received08/15/2006
Decision Date 12/21/2006
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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