Cleared Traditional

SIPHONGUARD CSF CONTROL DEVICE

K992173 · Johnson & Johnson Professionals, Inc. · Neurology
Apr 2000
Decision
284d
Days
Class 2
Risk

About This 510(k) Submission

K992173 is an FDA 510(k) clearance for the SIPHONGUARD CSF CONTROL DEVICE, a Shunt, Central Nervous System And Components (Class II — Special Controls, product code JXG), submitted by Johnson & Johnson Professionals, Inc. (Raynham, US). The FDA issued a Cleared decision on April 7, 2000, 284 days after receiving the submission on June 28, 1999. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5550.

Submission Details

510(k) Number K992173 FDA.gov
FDA Decision Cleared SESE
Date Received June 28, 1999
Decision Date April 07, 2000
Days to Decision 284 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code JXG — Shunt, Central Nervous System And Components
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5550

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