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FDA 510(k) Application Details - K020274
Device Classification Name
Prosthesis, Wrist, Hemi-, Ulnar
More FDA Info for this Device
510(K) Number
K020274
Device Name
Prosthesis, Wrist, Hemi-, Ulnar
Applicant
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 AIRLINE RD.
ARLINGTON, TN 38002 US
Other 510(k) Applications for this Company
Contact
EHAB M ESMAIL
Other 510(k) Applications for this Contact
Regulation Number
888.3810
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Classification Product Code
KXE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/28/2002
Decision Date
02/22/2002
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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