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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cuff, Nerve
510(k) Number K230794
Device Name Rebuilder Nerve Guidance Conduit
Applicant
CelestRay Biotech Company, LLC.,
PO BOX 341754
Bethesda,  MD  20827 -1754
Applicant Contact Charles C. Han
Correspondent
CelestRay Biotech Company, LLC.,
PO BOX 341754
Bethesda,  MD  20827 -1754
Correspondent Contact Charles C. Han
Regulation Number882.5275
Classification Product Code
JXI  
Date Received03/22/2023
Decision Date 01/29/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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