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FDA 510(k) Application Details - K080101
Device Classification Name
Screw, Fixation, Bone
More FDA Info for this Device
510(K) Number
K080101
Device Name
Screw, Fixation, Bone
Applicant
AAP IMPLANTATE AG
LORENZWEG 5
BERLIN 12099 DE
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Contact
MARC SEEGERS
Other 510(k) Applications for this Contact
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
01/14/2008
Decision Date
03/25/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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