Cleared Traditional

Plus Surgical Drapes (EO Sterilized), PMDB-XXX

K133080 · Foshan Nanhai Plus Medical Co, Ltd. · General Hospital
Jun 2015
Decision
632d
Days
Class 2
Risk

About This 510(k) Submission

K133080 is an FDA 510(k) clearance for the Plus Surgical Drapes (EO Sterilized), PMDB-XXX, a Drape, Surgical (Class II — Special Controls, product code KKX), submitted by Foshan Nanhai Plus Medical Co, Ltd. (Dover, US). The FDA issued a Cleared decision on June 24, 2015, 632 days after receiving the submission on September 30, 2013. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4370.

Submission Details

510(k) Number K133080 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2013
Decision Date June 24, 2015
Days to Decision 632 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

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

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