Cleared Special

PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKS

K081633 · Primed Medical Products, Inc. · General Hospital
Aug 2008
Decision
61d
Days
Class 2
Risk

About This 510(k) Submission

K081633 is an FDA 510(k) clearance for the PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKS, a Mask, Surgical (Class II — Special Controls, product code FXX), submitted by Primed Medical Products, Inc. (Edmonton, Alberta, CA). The FDA issued a Cleared decision on August 11, 2008, 61 days after receiving the submission on June 11, 2008. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K081633 FDA.gov
FDA Decision Cleared SESE
Date Received June 11, 2008
Decision Date August 11, 2008
Days to Decision 61 days
Submission Type Special
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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