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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Exhaust, Surgical
510(k) Number K182224
Device Name SafeAir Smoke Evacuator compact
Applicant
Lina Medical Aps
Ul. Rolna 8a, Sady
Tarnowo Podgorne,  PL 62-080
Applicant Contact Natalia Szychulska
Correspondent
Kevin F. Macdonald
4297 D St.
Sacramento,  CA  95819
Correspondent Contact Kevin F. MacDonald
Regulation Number878.5070
Classification Product Code
FYD  
Date Received08/16/2018
Decision Date 02/07/2019
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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