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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, femoral, resurfacing
510(k) Number K070292
Device Name DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS
Applicant
ZIMMER GMBH
PO BOX 708
WARSAW,  IN  46581
Applicant Contact ANTHONY FRANCALANCIA
Correspondent
ZIMMER GMBH
PO BOX 708
WARSAW,  IN  46581
Correspondent Contact ANTHONY FRANCALANCIA
Regulation Number888.3400
Classification Product Code
KXA  
Date Received01/31/2007
Decision Date 04/26/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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