Cleared Traditional

BUSSE HOSPITAL DISPOSABLES SPINAL MANOMETER

K032432 · Busse Hospital Disposables, Inc. · General Hospital
Aug 2003
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K032432 is an FDA 510(k) clearance for the BUSSE HOSPITAL DISPOSABLES SPINAL MANOMETER, a Manometer, Spinal-fluid (Class II — Special Controls, product code FMJ), submitted by Busse Hospital Disposables, Inc. (Huntington, US). The FDA issued a Cleared decision on August 28, 2003, 22 days after receiving the submission on August 6, 2003. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2500.

Submission Details

510(k) Number K032432 FDA.gov
FDA Decision Cleared SESE
Date Received August 06, 2003
Decision Date August 28, 2003
Days to Decision 22 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