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FDA 510(k) Application Details - K963739
Device Classification Name
Screw, Fixation, Bone
More FDA Info for this Device
510(K) Number
K963739
Device Name
Screw, Fixation, Bone
Applicant
HOWMEDICA LEIBINGER, INC.
14540 BELTWOOD PARKWAY EAST
DALLAS, TX 75244 US
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Contact
ANDREW B ROGERS
Other 510(k) Applications for this Contact
Regulation Number
888.3040
More FDA Info for this Regulation Number
Classification Product Code
HWC
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More FDA Info for this Product Code
Date Received
09/17/1996
Decision Date
01/22/1997
Decision
SN - Substantially Equivalent for Some Indications
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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