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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
510(k) Number K032824
Device Name STELKAST UNICONDYLAR KNEE SYSTEM
Applicant
Stelkast Company
200 Hidden Valley Rd.
Mcmurray,  PA  15317
Applicant Contact DONALD STEVENS
Correspondent
Stelkast Company
200 Hidden Valley Rd.
Mcmurray,  PA  15317
Correspondent Contact DONALD STEVENS
Regulation Number888.3520
Classification Product Code
HSX  
Date Received09/10/2003
Decision Date 11/13/2003
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
Recalls CDRH Recalls
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