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FDA 510(k) Application Details - K955916
Device Classification Name
Prosthesis, Elbow, Constrained, Cemented
More FDA Info for this Device
510(K) Number
K955916
Device Name
Prosthesis, Elbow, Constrained, Cemented
Applicant
BIOLOGICALLY ORIENTED PROSTHESES
17 SEVENTEENTH ST.
PORT HURON, MI 48060 US
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Contact
CHERYL L WARSINSKE
Other 510(k) Applications for this Contact
Regulation Number
888.3150
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Classification Product Code
JDC
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More FDA Info for this Product Code
Date Received
12/29/1995
Decision Date
08/08/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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