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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 K070061
Device Name 36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT
Applicant
Hayes Medical, Inc.
1115 Windfield Way, Suite 100
El Dorado Hills,  CA  95762 -9623
Applicant Contact LUKE ROSE
Correspondent
Hayes Medical, Inc.
1115 Windfield Way, Suite 100
El Dorado Hills,  CA  95762 -9623
Correspondent Contact LUKE ROSE
Regulation Number888.3360
Classification Product Code
LWJ  
Subsequent Product Codes
JDI   LPH  
Date Received01/05/2007
Decision Date 01/31/2007
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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