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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 K230577
Device Name Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL)
Applicant
Medcare Saglik Urunleri Sanayi VE Ticaret Anonim Sirketi
Fatih Mah. Camlik Cad No 54
Izmir,  TR 35410
Applicant Contact Muge Ersahin
Correspondent
Iuvo Consulting, LLC
P.O. Box 56436
Virginia Beach,  VA  23456
Correspondent Contact Rhonda Alexander
Regulation Number878.4040
Classification Product Code
FYA  
Date Received03/01/2023
Decision Date 08/16/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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