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FDA 510(k) Application Details - K961051
Device Classification Name
Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained
More FDA Info for this Device
510(K) Number
K961051
Device Name
Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained
Applicant
KINETIKOS MEDICAL, INC.
3950 SORRENTO VALLEY BLVD.,
SAN DIEGO, CA 92121 US
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Contact
MARK G URBANSKI
Other 510(k) Applications for this Contact
Regulation Number
888.3800
More FDA Info for this Regulation Number
Classification Product Code
JWJ
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More FDA Info for this Product Code
Date Received
03/11/1996
Decision Date
06/06/1996
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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