Cleared Traditional

FACE SHIELDS

K822004 · Kelleher Corp. · Gastroenterology & Urology
Oct 1982
Decision
104d
Days
Class 2
Risk

About This 510(k) Submission

K822004 is an FDA 510(k) clearance for the FACE SHIELDS, a Tubes, Gastrointestinal (and Accessories) (Class II — Special Controls, product code KNT), submitted by Kelleher Corp. (Mchenry, US). The FDA issued a Cleared decision on October 20, 1982, 104 days after receiving the submission on July 8, 1982. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.

Submission Details

510(k) Number K822004 FDA.gov
FDA Decision Cleared SESE
Date Received July 08, 1982
Decision Date October 20, 1982
Days to Decision 104 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code KNT — Tubes, Gastrointestinal (and Accessories)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5980

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