Cleared Traditional

GLOBAL MEDICAL PRODUCTS TUOHY & CRAWFORD EPIDURAL NEEDLE W/PLASTIC HUB

K952275 · Global Medical Prods, Inc. · Anesthesiology
Oct 1995
Decision
149d
Days
Class 2
Risk

About This 510(k) Submission

K952275 is an FDA 510(k) clearance for the GLOBAL MEDICAL PRODUCTS TUOHY & CRAWFORD EPIDURAL NEEDLE W/PLASTIC HUB, a Needle, Conduction, Anesthetic (w/wo Introducer) (Class II — Special Controls, product code BSP), submitted by Global Medical Prods, Inc. (Clearwater, US). The FDA issued a Cleared decision on October 11, 1995, 149 days after receiving the submission on May 15, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5150.

Submission Details

510(k) Number K952275 FDA.gov
FDA Decision Cleared SESE
Date Received May 15, 1995
Decision Date October 11, 1995
Days to Decision 149 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code BSP — Needle, Conduction, Anesthetic (w/wo Introducer)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5150

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