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FDA 510(k) Application Details - K994152
Device Classification Name
Screw, Fixation, Bone
More FDA Info for this Device
510(K) Number
K994152
Device Name
Screw, Fixation, Bone
Applicant
CORIN U.S.A.
10500 UNIVERSITY CENTER DR.,
SUITE 190
TAMPA, FL 33612 US
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Contact
CRAIG CORRANCE
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
12/08/1999
Decision Date
03/06/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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