Cleared Traditional

PMT SUBARACHNOID SCREW, MODEL NO.1350-2

K883115 · Pmt Corp. · Neurology
Aug 1988
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K883115 is an FDA 510(k) clearance for the PMT SUBARACHNOID SCREW, MODEL NO.1350-2, a Device, Monitoring, Intracranial Pressure (Class II — Special Controls, product code GWM), submitted by Pmt Corp. (Chanhassen, US). The FDA issued a Cleared decision on August 29, 1988, 35 days after receiving the submission on July 25, 1988. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1620.

Submission Details

510(k) Number K883115 FDA.gov
FDA Decision Cleared SESE
Date Received July 25, 1988
Decision Date August 29, 1988
Days to Decision 35 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary —

Device Classification

Product Code GWM — Device, Monitoring, Intracranial Pressure
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1620

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