Cleared Traditional

AESTHESIOMETER

K772406 · Fred Sammons, Inc. · Neurology
Jan 1978
Decision
10d
Days
Class 1
Risk

About This 510(k) Submission

K772406 is an FDA 510(k) clearance for the AESTHESIOMETER, a Esthesiometer (Class I — General Controls, product code GXB), submitted by Fred Sammons, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 6, 1978, 10 days after receiving the submission on December 27, 1977. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1500.

Submission Details

510(k) Number K772406 FDA.gov
FDA Decision Cleared SESE
Date Received December 27, 1977
Decision Date January 06, 1978
Days to Decision 10 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary —

Device Classification

Product Code GXB — Esthesiometer
Device Class Class I — General Controls
CFR Regulation 21 CFR 882.1500