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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K231877
Device Name NavaClick Injection System
Applicant
Lineage Biomedical, Inc.
620 NW Dixie Hwy
Stuart,  FL  34994
Applicant Contact Bradley Pliskow
Correspondent
Lineage Biomedical, Inc.
620 NW Dixie Hwy
Stuart,  FL  34994
Correspondent Contact Bradley Pliskow
Regulation Number880.5860
Classification Product Code
FMF  
Subsequent Product Codes
FMI   LHI  
Date Received06/26/2023
Decision Date 11/30/2023
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
Recalls CDRH Recalls
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