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FDA 510(k) Application Details - K013527
Device Classification Name
Reamer
More FDA Info for this Device
510(K) Number
K013527
Device Name
Reamer
Applicant
SYNTHES (USA)
1690 RUSSELL RD.
PAOLI, PA 19301 US
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Contact
BONNIE J SMITH
Other 510(k) Applications for this Contact
Regulation Number
888.4540
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Classification Product Code
HTO
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More FDA Info for this Product Code
Date Received
10/23/2001
Decision Date
12/21/2001
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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