Cleared Traditional

K051852 - SINGLE AMPLIFIER FOR BOTOX
(FDA 510(k) Clearance)

K051852 · Allergan, Inc. · Neurology
Sep 2005
Decision
68d
Days
Class 2
Risk

K051852 is an FDA 510(k) clearance for the SINGLE AMPLIFIER FOR BOTOX, a Amplifier, Physiological Signal (Class II — Special Controls, product code GWL), submitted by Allergan, Inc. (Irvine, US). The FDA issued a Cleared decision on September 14, 2005, 68 days after receiving the submission on July 8, 2005. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1835.

Submission Details

510(k) Number K051852 FDA.gov
FDA Decision Cleared SESE
Date Received July 08, 2005
Decision Date September 14, 2005
Days to Decision 68 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement

Device Classification

Product Code GWL — Amplifier, Physiological Signal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1835