Cleared Traditional

TEMP-TESTER

K771847 · Jablecki, Charles, Dr. · Chemistry
Nov 1977
Decision
35d
Days
Class 1
Risk

About This 510(k) Submission

K771847 is an FDA 510(k) clearance for the TEMP-TESTER, a Esthesiometer (Class I — General Controls, product code GXB), submitted by Jablecki, Charles, Dr. (Mchenry, US). The FDA issued a Cleared decision on November 2, 1977, 35 days after receiving the submission on September 28, 1977. This device falls under the Chemistry review panel. Regulated under 21 CFR 882.1500.

Submission Details

510(k) Number K771847 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 1977
Decision Date November 02, 1977
Days to Decision 35 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

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