Cleared Traditional

K791635 - AO TEACHING ATTACHMENT, MODEL TA-1
(FDA 510(k) Clearance)

K791635 · American Optical Corp. · Gastroenterology & Urology
Sep 1979
Decision
34d
Days
Class 1
Risk

K791635 is an FDA 510(k) clearance for the AO TEACHING ATTACHMENT, MODEL TA-1. This device is classified as a Attachment, Teaching, For Endoscope (Class I — General Controls, product code FEA).

Submitted by American Optical Corp. (Mchenry, US). The FDA issued a Cleared decision on September 24, 1979, 34 days after receiving the submission on August 21, 1979.

This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number K791635 FDA.gov
FDA Decision Cleared SESE
Date Received August 21, 1979
Decision Date September 24, 1979
Days to Decision 34 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code FEA — Attachment, Teaching, For Endoscope
Device Class Class I — General Controls
CFR Regulation 21 CFR 876.1500