Cleared Traditional

Cardinal Health Non-Reinforced Surgical Gown

K170762 · Cardinal Health200, LLC · General Hospital
Jun 2017
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K170762 is an FDA 510(k) clearance for the Cardinal Health Non-Reinforced Surgical Gown, a Gown, Surgical (Class II — Special Controls, product code FYA), submitted by Cardinal Health200, LLC (Waukegan, US). The FDA issued a Cleared decision on June 9, 2017, 88 days after receiving the submission on March 13, 2017. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K170762 FDA.gov
FDA Decision Cleared SESE
Date Received March 13, 2017
Decision Date June 09, 2017
Days to Decision 88 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FYA — Gown, Surgical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4040

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