Cleared Traditional

NEO-CARE LUMBER PUNCTURE KIT

K970997 · Klein-Baker Medical, Inc. · Anesthesiology
May 1997
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K970997 is an FDA 510(k) clearance for the NEO-CARE LUMBER PUNCTURE KIT, a Needle, Spinal, Short Term (Class II — Special Controls, product code MIA), submitted by Klein-Baker Medical, Inc. (San Antonio, US). The FDA issued a Cleared decision on May 22, 1997, 64 days after receiving the submission on March 19, 1997. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5150.

Submission Details

510(k) Number K970997 FDA.gov
FDA Decision Cleared SESE
Date Received March 19, 1997
Decision Date May 22, 1997
Days to Decision 64 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

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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