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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Absorbable Lung Biopsy Plug
510(k) Number K243722
Device Name Pre-B Seal Lung Biopsy Plug System - 15cm Model (FG0001); Pre-B Seal Lung Biopsy Plug System - 16cm Model (FG0002); Pre-B Seal Lung Biopsy Plug System - 20cm Model (FG0003)
Applicant
Selio Medical Limited
Unit 53 Guinness Enterprise Centre,
Taylors Lane, Dublin 8
Dublin,  IE D08 R9YW
Applicant Contact Colm McGarvey
Correspondent
Selio Medical Limited
Unit 53 Guinness Enterprise Centre,
Taylors Lane, Dublin 8
Dublin,  IE D08 R9YW
Correspondent Contact Colm McGarvey
Regulation Number878.4755
Classification Product Code
OMT  
Date Received12/03/2024
Decision Date 04/08/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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