Cleared Traditional

TRANSFORMER

K822267 · Kelleher Corp. · Gastroenterology & Urology
Oct 1982
Decision
76d
Days
Risk

About This 510(k) Submission

K822267 is an FDA 510(k) clearance for the TRANSFORMER, submitted by Kelleher Corp. (Mchenry, US). The FDA issued a Cleared decision on October 13, 1982, 76 days after receiving the submission on July 29, 1982. This device falls under the Gastroenterology & Urology review panel.

Submission Details

510(k) Number K822267 FDA.gov
FDA Decision Cleared SESE
Date Received July 29, 1982
Decision Date October 13, 1982
Days to Decision 76 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary

Device Classification

Product Code
Device Class