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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 K203565
Device Name Surgical 3D Mask
Applicant
Inno Lifecare
1615 Kebet Way
Port Coquitlam,  CA V3C 5W9
Applicant Contact Jae Ho Lee
Correspondent
Licensale, Inc.
3422 Leonardo Ln.
New Smyrna,  FL  32168
Correspondent Contact Raymond Kelly
Regulation Number878.4040
Classification Product Code
FXX  
Date Received12/07/2020
Decision Date 10/19/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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