Cleared Traditional

ESPOCAN COMBINED SPINAL/EPIDURAL NEEDLE SET & TRAY

K932400 · B. Braun of America, Inc. · Anesthesiology
Dec 1993
Decision
209d
Days
Class 2
Risk

About This 510(k) Submission

K932400 is an FDA 510(k) clearance for the ESPOCAN COMBINED SPINAL/EPIDURAL NEEDLE SET & TRAY, a Needle, Conduction, Anesthetic (w/wo Introducer) (Class II — Special Controls, product code BSP), submitted by B. Braun of America, Inc. (Bethlehem, US). The FDA issued a Cleared decision on December 13, 1993, 209 days after receiving the submission on May 18, 1993. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5150.

Submission Details

510(k) Number K932400 FDA.gov
FDA Decision Cleared SEKD
Date Received May 18, 1993
Decision Date December 13, 1993
Days to Decision 209 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

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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