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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 K221134
Device Name Procedure Mask with Ear Loops and Surgical Mask with Ties
Applicant
Safesource Direct, LLC
200 St. Nazaire Rd.
Broussard,  LA  70518
Applicant Contact Robbie Wicks
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number878.4040
Classification Product Code
FXX  
Date Received04/19/2022
Decision Date 05/19/2022
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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