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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name gown, surgical
510(k) Number K221139
Device Name Bodygard SFS Surgical Gown Level 4
Applicant
Feliks Plastik Laminasyon Ve Ambalaj Malzemeleri
Sanayi ve Tic A. S.
Eskisehir Organize Sanayi Bolgesi 26, Cadde No. 9
Odunpazari,  TR 26110
Applicant Contact Ali Serdar Serteser
Correspondent
DP Distribution & Consulting, LLC
12240 Hunting Horn Lane
Rockville,  VA  23146
Correspondent Contact Darren Reeves
Regulation Number878.4040
Classification Product Code
FYA  
Date Received04/19/2022
Decision Date 11/10/2022
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
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