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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 K212111
Device Name Myflon Surgical Mask Level 3
Applicant
Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi
Ve Tic A.S.
Eskisehir Industrial Zone 26th St. No 9
Eskisehir,  TR 26100
Applicant Contact Ali Serdar Serteser
Correspondent
Rogers Consulting
11110 Arranmore Cove
Roanoke,  IN  46783
Correspondent Contact W. Victoria Rogers
Regulation Number878.4040
Classification Product Code
FXX  
Date Received07/06/2021
Decision Date 01/23/2022
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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