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FDA 510(k) Application Details - K032532
Device Classification Name
Pin, Fixation, Threaded
More FDA Info for this Device
510(K) Number
K032532
Device Name
Pin, Fixation, Threaded
Applicant
UNION SURGICAL LLC
834 CHESTNUT STREET
SUITE G114
PHILADELPHIA, PA 19107 US
Other 510(k) Applications for this Company
Contact
AL WEISENBORN
Other 510(k) Applications for this Contact
Regulation Number
888.3040
More FDA Info for this Regulation Number
Classification Product Code
JDW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/15/2003
Decision Date
10/22/2003
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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