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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Surgical
510(k) Number K212302
Device Name BAYLAB 3-Ply Surgical Mask (BEACON I)
Applicant
Baylab USA, LLC
2230 Lyndon B Johnson Fwy., Suite 100
Dallas,  TX  75234
Applicant Contact Ashley Park
Correspondent
Freyr Solutions
Level 4, Bldg. # H-08, Phoenix Sez
Phase 2, Gachibowli
Hyderabad,  IN 500081
Correspondent Contact Vardhini Kirthivas
Regulation Number878.4040
Classification Product Code
FXX  
Date Received07/23/2021
Decision Date 12/07/2021
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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