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FDA 510(k) Application Details - K993004
Device Classification Name
Nail, Fixation, Bone
More FDA Info for this Device
510(K) Number
K993004
Device Name
Nail, Fixation, Bone
Applicant
HOWMEDICA OSTEONICS CORP.
359 VETERANS BLVD.
RUTHERFORD, NJ 07070-2584 US
Other 510(k) Applications for this Company
Contact
JENNIFER A DAUDELIN
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
JDS
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More FDA Info for this Product Code
Date Received
09/07/1999
Decision Date
10/06/1999
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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