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FDA 510(k) Application Details - K030037
Device Classification Name
Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained
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510(K) Number
K030037
Device Name
Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained
Applicant
KINETIKOS MEDICAL, INC.
6005 HIDDEN VALLEY RD, STE 180
CARLSBAD, CA 92011 US
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Contact
JOHN SPAMPINATO
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Regulation Number
888.3800
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Classification Product Code
JWJ
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Date Received
01/06/2003
Decision Date
02/05/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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