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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, Cemented
510(k) Number K030867
Device Name ESKA MODULAR HIP SYSTEM CEMENTED
Applicant
Eska Implants GmbH
101 Riverfront Blvd.
Suite 600
Bradenton,  FL  34205
Applicant Contact THOMAS P MONKUS
Correspondent
Eska Implants GmbH
101 Riverfront Blvd.
Suite 600
Bradenton,  FL  34205
Correspondent Contact THOMAS P MONKUS
Regulation Number888.3350
Classification Product Code
JDI  
Date Received03/19/2003
Decision Date 09/22/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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