Cleared Traditional

MEGA LUMBAR PUNCTURE KIT

K910089 · Megadyne Medical Products, Inc. · General Hospital
Jun 1991
Decision
162d
Days
Class 2
Risk

About This 510(k) Submission

K910089 is an FDA 510(k) clearance for the MEGA LUMBAR PUNCTURE KIT, a Manometer, Spinal-fluid (Class II — Special Controls, product code FMJ), submitted by Megadyne Medical Products, Inc. (Tampa, US). The FDA issued a Cleared decision on June 20, 1991, 162 days after receiving the submission on January 9, 1991. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2500.

Submission Details

510(k) Number K910089 FDA.gov
FDA Decision Cleared SESK
Date Received January 09, 1991
Decision Date June 20, 1991
Days to Decision 162 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

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

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