Cleared Traditional

K760851 - CONVERSE ALTAR RETRACTOR
(FDA 510(k) Clearance)

Mar 1977
Decision
146d
Days
Class 1
Risk

K760851 is an FDA 510(k) clearance for the CONVERSE ALTAR RETRACTOR. This device is classified as a Retractor, Ent (Class I - General Controls, product code KAL).

Submitted by V. Mueller O.V. Baxter Healthcare Corp. (Mchenry, US). The FDA issued a Cleared decision on March 10, 1977, 146 days after receiving the submission on October 15, 1976.

This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4420.

Submission Details

510(k) Number K760851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1976
Decision Date March 10, 1977
Days to Decision 146 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary

Device Classification

Product Code KAL — Retractor, Ent
Device Class Class I - General Controls
CFR Regulation 21 CFR 874.4420