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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 K960180
Device Name 22 MM COCR HEAD & POLYETHLENE LINER
Applicant
Stelkast Company
800 Vinial St. #210
Pittsburgh,  PA  15212
Applicant Contact DONALD A STEVENS
Correspondent
Stelkast Company
800 Vinial St. #210
Pittsburgh,  PA  15212
Correspondent Contact DONALD A STEVENS
Regulation Number888.3358
Classification Product Code
LPH  
Date Received01/16/1996
Decision Date 05/02/1996
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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