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FDA 510(k) Application Details - K053119
Device Classification Name
Prosthesis, Wrist, Hemi-, Ulnar
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510(K) Number
K053119
Device Name
Prosthesis, Wrist, Hemi-, Ulnar
Applicant
APTIS MEDICAL, LLC.
5 RIVER HILL RD.
LOUISVILLE, KY 40207 US
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Contact
BRYAN BABB
Other 510(k) Applications for this Contact
Regulation Number
888.3810
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Classification Product Code
KXE
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More FDA Info for this Product Code
Date Received
11/07/2005
Decision Date
12/07/2005
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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