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FDA 510(k) Application Details - K955710
Device Classification Name
Screw, Fixation, Bone
More FDA Info for this Device
510(K) Number
K955710
Device Name
Screw, Fixation, Bone
Applicant
J.B.S. (USA), INC.
206 E. BLITHEDALE AVE.
MILL VALLEY, CA 96961 US
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Contact
RICHARD DI TAIO
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Regulation Number
888.3040
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Classification Product Code
HWC
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More FDA Info for this Product Code
Date Received
12/14/1995
Decision Date
03/04/1996
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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