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FDA 510(k) Application Details - K042143
Device Classification Name
Appliance, Fixation, Spinal Interlaminal
More FDA Info for this Device
510(K) Number
K042143
Device Name
Appliance, Fixation, Spinal Interlaminal
Applicant
INNOVASIS, INC.
997 EAST 3900 SOUTH
SUITE 103
SALT LAKE CITY, UT 84124 US
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Contact
BRENT A FELIX
Other 510(k) Applications for this Contact
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
08/09/2004
Decision Date
10/07/2004
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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