HONGYU DISPOSABLE SURGICAL DRAPES— 510(k) K141324

Name: FDA 510(k) clearance K141324
Creator: U.S. Food and Drug Administration
Published: 2015-04-14

Substantially Equivalent

Weihai Hongyu Nonwoven Fabric Products Co., Ltd.

FDA 510(k) clearance K141324 for HONGYU DISPOSABLE SURGICAL DRAPES, Substantially Equivalent on 2015-04-14. Applicant: Weihai Hongyu Nonwoven Fabric Products Co., Ltd.. Device class: 2.

Clearance details

Applicant: Weihai Hongyu Nonwoven Fabric Products Co., Ltd.
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 2014-05-20
Decision date: 2015-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

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