Cleared Traditional

Pasture 60S Surgical Mask

K141875 · Pasture Pharma Pte, Ltd. · General Hospital
May 2015
Decision
298d
Days
Class 2
Risk

About This 510(k) Submission

K141875 is an FDA 510(k) clearance for the Pasture 60S Surgical Mask, a Mask, Surgical (Class II — Special Controls, product code FXX), submitted by Pasture Pharma Pte, Ltd. (Murrieta, US). The FDA issued a Cleared decision on May 5, 2015, 298 days after receiving the submission on July 11, 2014. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K141875 FDA.gov
FDA Decision Cleared SESE
Date Received July 11, 2014
Decision Date May 05, 2015
Days to Decision 298 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FXX — Mask, Surgical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4040

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