Cleared Traditional

PRIMED Surgical Masks and PRIMED Procedure Masks

K240286 · Primed Medical Products, Inc. · General Hospital
Aug 2024
Decision
207d
Days
Class 2
Risk

About This 510(k) Submission

K240286 is an FDA 510(k) clearance for the PRIMED Surgical Masks and PRIMED Procedure Masks, a Mask, Surgical (Class II — Special Controls, product code FXX), submitted by Primed Medical Products, Inc. (Edmonton, CA). The FDA issued a Cleared decision on August 26, 2024, 207 days after receiving the submission on February 1, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K240286 FDA.gov
FDA Decision Cleared SESE
Date Received February 01, 2024
Decision Date August 26, 2024
Days to Decision 207 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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