Cleared Traditional

SIMS ADULT LUMBAR PUNCTURE KIT (4800-20,4801-20,4806-22,4807-22)

K963570 · Smiths Industries Medical Systems, Inc. · General Hospital
Oct 1996
Decision
43d
Days
Class 2
Risk

About This 510(k) Submission

K963570 is an FDA 510(k) clearance for the SIMS ADULT LUMBAR PUNCTURE KIT (4800-20,4801-20,4806-22,4807-22), a Manometer, Spinal-fluid (Class II — Special Controls, product code FMJ), submitted by Smiths Industries Medical Systems, Inc. (Keene, US). The FDA issued a Cleared decision on October 18, 1996, 43 days after receiving the submission on September 5, 1996. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2500.

Submission Details

510(k) Number K963570 FDA.gov
FDA Decision Cleared SESE
Date Received September 05, 1996
Decision Date October 18, 1996
Days to Decision 43 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMJ — Manometer, Spinal-fluid
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.2500