Cleared Traditional

ESOPHAGEAL DILATOR SET

K842679 · Mill-Rose Laboratory · Gastroenterology & Urology
Oct 1984
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K842679 is an FDA 510(k) clearance for the ESOPHAGEAL DILATOR SET, a Bougie, Esophageal, And Gastrointestinal, Gastro-urology (Class II — Special Controls, product code FAT), submitted by Mill-Rose Laboratory (Mchenry, US). The FDA issued a Cleared decision on October 2, 1984, 84 days after receiving the submission on July 10, 1984. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5365.

Submission Details

510(k) Number K842679 FDA.gov
FDA Decision Cleared SESE
Date Received July 10, 1984
Decision Date October 02, 1984
Days to Decision 84 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code FAT — Bougie, Esophageal, And Gastrointestinal, Gastro-urology
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5365

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