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510(k) K214088

Disposable Surgical Gown by Weihai Hongyu Nonwoven Fabric Products Co., Ltd. — Product Code FYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 2022
Date Received
December 28, 2021
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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