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FDA 510(k) Application Details - K193603
Device Classification Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
More FDA Info for this Device
510(K) Number
K193603
Device Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant
Caldera Medical, Inc
5171 Clareton Drive
Agoura Hills, CA 91301 US
Other 510(k) Applications for this Company
Contact
Vicki Gail
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
12/23/2019
Decision Date
07/20/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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