Cleared Traditional

PAIN DOC

K941342 · Regulatory & Marketing Services, Inc. · Neurology
Oct 1995
Decision
598d
Days
Class 2
Risk

About This 510(k) Submission

K941342 is an FDA 510(k) clearance for the PAIN DOC, a Stimulator, Spinal-cord, Implanted (pain Relief) (Class II — Special Controls, product code GZB), submitted by Regulatory & Marketing Services, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on October 13, 1995, 598 days after receiving the submission on February 22, 1994. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5880.

Submission Details

510(k) Number K941342 FDA.gov
FDA Decision Cleared SESE
Date Received February 22, 1994
Decision Date October 13, 1995
Days to Decision 598 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement

Device Classification

Product Code GZB — Stimulator, Spinal-cord, Implanted (pain Relief)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5880

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