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FDA 510(k) Application Details - K950999
Device Classification Name
Orthosis, Spondyloisthesis Spinal Fixation
More FDA Info for this Device
510(K) Number
K950999
Device Name
Orthosis, Spondyloisthesis Spinal Fixation
Applicant
BUCKMAN CO., INC.
1000 BURNETT AVE.
SUITE 450
CONCORD, CA 94520 US
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Contact
DAVID W SCHLERF
Other 510(k) Applications for this Contact
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
03/03/1995
Decision Date
01/25/1996
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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