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FDA 510(k) Application Details - K180853
Device Classification Name
Filler, Bone Void, Calcium Compound
More FDA Info for this Device
510(K) Number
K180853
Device Name
Filler, Bone Void, Calcium Compound
Applicant
Elute, Inc.
417 Wakara Way Suite 3510
Salt Lake City, UT 84108 US
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Contact
Kirk Andriano
Other 510(k) Applications for this Contact
Regulation Number
888.3045
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Classification Product Code
MQV
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/02/2018
Decision Date
08/06/2018
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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