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FDA 510(k) Application Details - K163600
Device Classification Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
More FDA Info for this Device
510(K) Number
K163600
Device Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant
Nobel Biocare AB
Vastra Hamngatan 1
Goteborg SE-411 17 SE
Other 510(k) Applications for this Company
Contact
Charlemagne Chua
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
12/21/2016
Decision Date
01/22/2018
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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