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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 K182354
Device Name SafeAir Telescopic Smoke Pencil
Applicant
Lina Medical Aps
Formervangen 5
Glostrup,  DK 2600
Applicant Contact Natalia Szychulska
Correspondent
Macdonald Regulatory Consulting
4297 D St.
Sacramento,  CA  95819
Correspondent Contact Kevin F. Macdonald
Regulation Number878.4400
Classification Product Code
GEI  
Date Received08/29/2018
Decision Date 12/14/2018
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
Recalls CDRH Recalls
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