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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopaedic Surgical Planning And Instrument Guides
510(k) Number K221943
FOIA Releasable 510(k) K221943
Device Name EmbedMed
Applicant
3D Lifeprints UK , Ltd.
The Innovation Hub, Alder Hey Children'S Nhs Foundation
Trust, Eaton Rd.
West Derby, Liverpool, Merseyside,  GB L12 2AP
Applicant Contact Henry Pinchbeck
Correspondent
Olympus Regulatory Solutions
5 Seaconnet Ave.
Portsmouth,  RI  02871
Correspondent Contact Sam Murray
Regulation Number888.3030
Classification Product Code
PBF  
Subsequent Product Code
LLZ  
Date Received07/05/2022
Decision Date 02/01/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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