Cleared Traditional

CATCO NEONATAL PALATE GUARD

K945727 · Catco Medical, Inc. · Anesthesiology
Dec 1994
Decision
15d
Days
Class 1
Risk

About This 510(k) Submission

K945727 is an FDA 510(k) clearance for the CATCO NEONATAL PALATE GUARD, a Protector, Dental (Class I — General Controls, product code BRW), submitted by Catco Medical, Inc. (San Antonio, US). The FDA issued a Cleared decision on December 7, 1994, 15 days after receiving the submission on November 22, 1994. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5820.

Submission Details

510(k) Number K945727 FDA.gov
FDA Decision Cleared SESE
Date Received November 22, 1994
Decision Date December 07, 1994
Days to Decision 15 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code BRW — Protector, Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5820