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FDA 510(k) Application Details - K170939
Device Classification Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
More FDA Info for this Device
510(K) Number
K170939
Device Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant
NuVasive Specialized Orthopedics, Incorporated
101 Enterprise
Aliso Viejo, CA 92656 US
Other 510(k) Applications for this Company
Contact
Cora Sim
Other 510(k) Applications for this Contact
Regulation Number
880.6850
More FDA Info for this Regulation Number
Classification Product Code
KCT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/30/2017
Decision Date
08/08/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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