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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 K220520
Device Name PM Excellence SEQUR 100 Surgical Face Mask
Applicant
Pm Excellence, LLC
2864 Wilson Ave.
Bellmore,  NY  11710
Applicant Contact Nina Bektic-Marrero
Correspondent
Pm Excellence, LLC
2864 Wilson Ave.
Bellmore,  NY  11710
Correspondent Contact Nina Bektic-Marrero
Regulation Number878.4040
Classification Product Code
FXX  
Date Received02/23/2022
Decision Date 12/15/2022
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		 No
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