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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 K202214
Device Name IFM Surgical Mask Model SM3
Applicant
FSSC, LLC
3300 West Clark St.
Rensselaer,  IN  47978
Applicant Contact Clayton Geyer
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 Received08/06/2020
Decision Date 03/02/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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