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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cutaneous Tissue Adhesive With Mesh
510(k) Number K211878
FOIA Releasable 510(k) K211878
Device Name LiquiBand XL
Applicant
Advanced Medical Solutions Limited
Western Wood Way
Langage Science Park
Plymouth,  GB PL7 5BG
Applicant Contact Martin Mitchell
Correspondent
Advanced Medical Solutions Limited
Western Wood Way
Langage Science Park
Plymouth,  GB PL7 5BG
Correspondent Contact Martin Mitchell
Regulation Number878.4011
Classification Product Code
OMD  
Date Received06/21/2021
Decision Date 05/23/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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