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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 K220637
Device Name 3 Ply Medical Grade Single Use Procedural Disposable Face Mask
Applicant
KDI Med Supply
206 Lynn St
Fremont,  OH  43420
Applicant Contact Yolanda Davis
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number878.4040
Classification Product Code
FXX  
Date Received03/04/2022
Decision Date 03/25/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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