Cleared Traditional

REGANES SPINAL NEEDLE (VARIOUS)

K971645 · Avid N.I.T., Inc. · Anesthesiology
Aug 1997
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K971645 is an FDA 510(k) clearance for the REGANES SPINAL NEEDLE (VARIOUS), a Needle, Spinal, Short Term (Class II — Special Controls, product code MIA), submitted by Avid N.I.T., Inc. (Tarpon Springs, US). The FDA issued a Cleared decision on August 1, 1997, 88 days after receiving the submission on May 5, 1997. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5150.

Submission Details

510(k) Number K971645 FDA.gov
FDA Decision Cleared SESE
Date Received May 05, 1997
Decision Date August 01, 1997
Days to Decision 88 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code MIA — Needle, Spinal, Short Term
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5150

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