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FDA 510(k) Application Details - K223672
Device Classification Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
More FDA Info for this Device
510(K) Number
K223672
Device Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant
Cochlear
10350 Park Meadows Drive
Lone Tree, CO 80124 US
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Contact
Denis DiMartino
Other 510(k) Applications for this Contact
Regulation Number
880.6850
More FDA Info for this Regulation Number
Classification Product Code
KCT
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More FDA Info for this Product Code
Date Received
12/07/2022
Decision Date
03/21/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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