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FDA 510(k) Application Details - K043297
Device Classification Name
Plate, Bone
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510(K) Number
K043297
Device Name
Plate, Bone
Applicant
MEDICON, E.G.
AMSTEL 320-1
AMSTERDAM 1017AP NL
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Contact
ANGELIKA SCHERP
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Regulation Number
872.4760
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Classification Product Code
JEY
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More FDA Info for this Product Code
Date Received
11/29/2004
Decision Date
02/23/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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