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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 K213844
Device Name Surgical Gown
Applicant
Bayteks Teknik Tekstil San. VE Tic. A.S.
Organize Sanaji Bolgesi 19. Nolu Cad. # 9
Merkez,  TR 79000
Applicant Contact Spero Hegbe
Correspondent
Emergo by UL
2500 Bee Cave Rd., Bldg. 1 Suite 300
Austin,  TX  78746
Correspondent Contact Sarah Marie Fitzgerald
Regulation Number878.4040
Classification Product Code
FYA  
Date Received12/09/2021
Decision Date 02/16/2023
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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