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FDA 510(k) Application Details - K011354
Device Classification Name
Plate, Fixation, Bone
More FDA Info for this Device
510(K) Number
K011354
Device Name
Plate, Fixation, Bone
Applicant
DJ ORTHOPEDICS, LLC
990 PARK CENTER DRIVE, SUITE H
VISTA, CA 92083 US
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Contact
JAMAL D RUSHDY
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
HRS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/03/2001
Decision Date
07/31/2001
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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