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510(k) Premarket Notification

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Device Classification Name prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, uncemented, polymer/metal/polymer
510(k) NumberK853730
Device NameFREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE REP
Applicant
PROTEK, INC.
one park fletcher
2601 fortune cir. e. ste.105b
indianapolis,  IN  46241
Contactkenneth epling
Regulation Number888.3560
Classification Product Code
MBV  
Date Received09/06/1985
Decision Date 02/18/1986
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
Statement/Summary/Purged Status Purged, no summary or statement
Type Traditional
Reviewed by Third Party No
Expedited Review
 
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