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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, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
510(k) Number K021908
Device Name PROVEN MODULAR POSTERIOR STABILIZED FEMORAL
Original Applicant
STELKAST COMPANY
200 hidden valley rd.
mcmurray,  PA  15317
Original Contact donald a stevens
Regulation Number888.3560
Classification Product Code
JWH  
Date Received06/10/2002
Decision Date 07/09/2002
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
statement statement
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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