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510(k) K203415

Surgical Isolation Gown by Yanbian Pacific Textile Co., Ltd. — Product Code FYC

K203415 is an FDA 510(k) premarket notification submitted by Yanbian Pacific Textile Co., Ltd. for the device "Surgical Isolation Gown". The FDA issued a decision of Substantially Equivalent on May 20, 2021. The device falls under product code FYC (Gown, Isolation, Surgical), a Class II device regulated under 21 CFR 878.4040.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 2021
Date Received
Nov 19, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gown, Isolation, Surgical
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type
510(k)

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FDA data resources