Cleared Traditional

1/310, 1-320 PERCUSSION HAMMERS,TAYLOR, DEJERINE

K851748 · Artiberia · Neurology
Jun 1985
Decision
49d
Days
Class 1
Risk

About This 510(k) Submission

K851748 is an FDA 510(k) clearance for the 1/310, 1-320 PERCUSSION HAMMERS,TAYLOR, DEJERINE, a Percussor (Class I — General Controls, product code GWZ), submitted by Artiberia (San Antonio, US). The FDA issued a Cleared decision on June 13, 1985, 49 days after receiving the submission on April 25, 1985. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1700.

Submission Details

510(k) Number K851748 FDA.gov
FDA Decision Cleared SESE
Date Received April 25, 1985
Decision Date June 13, 1985
Days to Decision 49 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary —

Device Classification

Product Code GWZ — Percussor
Device Class Class I — General Controls
CFR Regulation 21 CFR 882.1700