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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, Porous Uncemented
510(k) Number K021466
Device Name CONSENSUS ACETABULAR INSERT, CROSS-LINKED POLYETHYLENE
Applicant
Hayes Medical, Inc.
1115 Windfield Way, Suite 100
El Dorado Hills,  CA  95762 -9623
Applicant Contact WILLIAM J GRIFFIN
Correspondent
Hayes Medical, Inc.
1115 Windfield Way, Suite 100
El Dorado Hills,  CA  95762 -9623
Correspondent Contact WILLIAM J GRIFFIN
Regulation Number888.3358
Classification Product Code
LPH  
Date Received05/07/2002
Decision Date 07/24/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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