Cleared Special

PRIMAGARD DELTA FIT 80,120, 160 SURGICAL FACE MASK (SMALL, MEDIUM, LARGE) MODEL PG4-7061,-7071,-7081, PG4-7062, 7072-70

K092012 · Primed Medical Products, Inc. · General Hospital
Sep 2009
Decision
81d
Days
Class 2
Risk

About This 510(k) Submission

K092012 is an FDA 510(k) clearance for the PRIMAGARD DELTA FIT 80,120, 160 SURGICAL FACE MASK (SMALL, MEDIUM, LARGE) MODEL PG4-7061,-7071,-7081, PG4-7062, 7072-70, 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 September 25, 2009, 81 days after receiving the submission on July 6, 2009. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K092012 FDA.gov
FDA Decision Cleared SESE
Date Received July 06, 2009
Decision Date September 25, 2009
Days to Decision 81 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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