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FDA 510(k) Application Details - K051642
Device Classification Name
Plate, Fixation, Bone, Non-Spinal, Metallic
More FDA Info for this Device
510(K) Number
K051642
Device Name
Plate, Fixation, Bone, Non-Spinal, Metallic
Applicant
I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH
3150 E. 200TH ST.
PRIOR LAKE, MN 55372 US
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AL LIPPINCOTT
Other 510(k) Applications for this Contact
Regulation Number
888.3030
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Classification Product Code
NDF
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More FDA Info for this Product Code
Date Received
06/20/2005
Decision Date
08/22/2005
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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