Cleared Traditional

THE (CROM) TESTER

K870767 · Twin City Surgical, Inc. · Neurology
Mar 1987
Decision
19d
Days
Class 1
Risk

About This 510(k) Submission

K870767 is an FDA 510(k) clearance for the THE (CROM) TESTER, a Goniometer, Nonpowered (Class I — General Controls, product code KQW), submitted by Twin City Surgical, Inc. (St. Paul, US). The FDA issued a Cleared decision on March 17, 1987, 19 days after receiving the submission on February 26, 1987. This device falls under the Neurology review panel. Regulated under 21 CFR 888.1520.

Submission Details

510(k) Number K870767 FDA.gov
FDA Decision Cleared SESE
Date Received February 26, 1987
Decision Date March 17, 1987
Days to Decision 19 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary —

Device Classification

Product Code KQW — Goniometer, Nonpowered
Device Class Class I — General Controls
CFR Regulation 21 CFR 888.1520