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510(k) K230577

Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL) by Medcare Saglik Urunleri Sanayi VE Ticaret Anonim Sirketi — Product Code FYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2023
Date Received
March 1, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gown, Surgical
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type

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