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FDA 510(k) Application Details - K092011
Device Classification Name
Orthosis, Spondyloisthesis Spinal Fixation
More FDA Info for this Device
510(K) Number
K092011
Device Name
Orthosis, Spondyloisthesis Spinal Fixation
Applicant
NORM TIBBI URUNLER ITHALAT IHRACAT SANAYI VE TICAR
1CADDE NO:5/1 BALGAT
ANKARA 06520 TR
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NURAY DOGAN
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Regulation Number
888.3070
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Classification Product Code
MNH
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More FDA Info for this Product Code
Date Received
07/06/2009
Decision Date
10/28/2009
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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