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FDA 510(k) Application Details - K060513
Device Classification Name
Appliance, Fixation, Spinal Interlaminal
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510(K) Number
K060513
Device Name
Appliance, Fixation, Spinal Interlaminal
Applicant
SINTEA BIOTECH, INC.
407 LINCOLN RD. SUITE 10L
MIAMI BEACH, FL 33139 US
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GUSTAVO A RIOS
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Regulation Number
888.3050
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Classification Product Code
KWP
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More FDA Info for this Product Code
Date Received
02/27/2006
Decision Date
03/10/2006
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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