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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name sterilization wrap containers, trays, cassettes & other accessories
510(k) Number K193603
Device Name Benesta Medical Sterilization Tray
Applicant
Caldera Medical, Inc
5171 Clareton Drive
Agoura Hills,  CA  91301
Applicant Contact Vicki Gail
Correspondent
Caldera Medical, Inc
5171 Clareton Drive
Agoura Hills,  CA  91301
Correspondent Contact Vicki Gail
Regulation Number880.6850
Classification Product Code
KCT  
Date Received12/23/2019
Decision Date 07/20/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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