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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 K251902
Device Name Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield (Vitaform-FS)
Applicant
Vitacore Industries, Inc.
1615 Kebet Way
Port Coquitlam,  CA V3C 5W9
Applicant Contact Yuxuan Fan
Correspondent
Vitacore Industries, Inc.
1615 Kebet Way
Port Coquitlam,  CA V3C 5W9
Correspondent Contact Yuxuan Fan
Regulation Number878.4040
Classification Product Code
FXX  
Date Received06/20/2025
Decision Date 09/17/2025
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		 Yes
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