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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K223932
Device Name SafeAir combi (SFR-combi-US)
Applicant
Lina Medical Aps
Formervangen 5
Glostrup,  DK DK-2600
Applicant Contact Jaroslaw Mrowczynski
Correspondent
MEDIcept, Inc.
200 Homer Ave.
Ashland,  MA  01721
Correspondent Contact Scott Blood
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
FYD  
Date Received12/30/2022
Decision Date 04/26/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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