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FDA 510(k) Application Details - K080706
Device Classification Name
Nail, Fixation, Bone
More FDA Info for this Device
510(K) Number
K080706
Device Name
Nail, Fixation, Bone
Applicant
I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH
3150 E. 200TH ST.
PRIOR LAKE, MN 55372 US
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Contact
AL LIPPINCOTT
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
JDS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/12/2008
Decision Date
06/09/2008
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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