Cleared Abbreviated

Asept Surgical Face Mask

K201137 · Pfm Medical, Inc. · General Hospital
Aug 2020
Decision
113d
Days
Class 2
Risk

About This 510(k) Submission

K201137 is an FDA 510(k) clearance for the Asept Surgical Face Mask, a Mask, Surgical (Class II — Special Controls, product code FXX), submitted by Pfm Medical, Inc. (Carlsbad, US). The FDA issued a Cleared decision on August 19, 2020, 113 days after receiving the submission on April 28, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K201137 FDA.gov
FDA Decision Cleared SESE
Date Received April 28, 2020
Decision Date August 19, 2020
Days to Decision 113 days
Submission Type Abbreviated
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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