Cleared Traditional

ANTI-MIST, ANTI-FOG EYEGLASS & DENTAL

K822711 · Parker Laboratories, Inc. · Gastroenterology & Urology
Nov 1982
Decision
57d
Days
Class 1
Risk

About This 510(k) Submission

K822711 is an FDA 510(k) clearance for the ANTI-MIST, ANTI-FOG EYEGLASS & DENTAL, a Bougie, Urological (Class I — General Controls, product code FAX), submitted by Parker Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on November 3, 1982, 57 days after receiving the submission on September 7, 1982. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5520.

Submission Details

510(k) Number K822711 FDA.gov
FDA Decision Cleared SESE
Date Received September 07, 1982
Decision Date November 03, 1982
Days to Decision 57 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code FAX — Bougie, Urological
Device Class Class I — General Controls
CFR Regulation 21 CFR 876.5520