Cleared Traditional

HONGYU DISPOSABLE SURGICAL DRAPES

K141324 · Weihai Hongyu Nonwoven Fabric Products Co., Ltd. · General Hospital
Apr 2015
Decision
329d
Days
Class 2
Risk

About This 510(k) Submission

K141324 is an FDA 510(k) clearance for the HONGYU DISPOSABLE SURGICAL DRAPES, a Drape, Surgical (Class II — Special Controls, product code KKX), submitted by Weihai Hongyu Nonwoven Fabric Products Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on April 14, 2015, 329 days after receiving the submission on May 20, 2014. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4370.

Submission Details

510(k) Number K141324 FDA.gov
FDA Decision Cleared SESE
Date Received May 20, 2014
Decision Date April 14, 2015
Days to Decision 329 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code KKX — Drape, Surgical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4370

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