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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 K251756
Device Name Sterilization Trays
Applicant
Paragon Implant Mfg., LLC
27030 Malibu Hills Rd.
Calabasas,  CA  91301
Applicant Contact Renee Bennett
Correspondent
Paragon Implant Mfg., LLC
27030 Malibu Hills Rd.
Calabasas,  CA  91301
Correspondent Contact Renee Bennett
Regulation Number880.6850
Classification Product Code
KCT  
Date Received06/09/2025
Decision Date 11/14/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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