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FDA 510(k) Application Details - K101859
Device Classification Name
Joint, Knee, External Limb Component
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510(K) Number
K101859
Device Name
Joint, Knee, External Limb Component
Applicant
RIZZOLI ORTOPEDICA S.P.A.
58A BATES ROAD
WATERTOWN, MA 02472 US
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Contact
DIANE C TIERNAN, MS RAC
Other 510(k) Applications for this Contact
Regulation Number
890.3420
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Classification Product Code
ISY
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More FDA Info for this Product Code
Date Received
07/02/2010
Decision Date
10/13/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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