Cleared Traditional

MAXI-FLOW SUCTION HANDLE/THE REEL THING TUBING REEL

K955149 · Bio-Medical Devices, Inc. · General Hospital
Jan 1996
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K955149 is an FDA 510(k) clearance for the MAXI-FLOW SUCTION HANDLE/THE REEL THING TUBING REEL, a Tube, Aspirating, Flexible, Connecting (Class II — Special Controls, product code BYY), submitted by Bio-Medical Devices, Inc. (Irvine, US). The FDA issued a Cleared decision on January 24, 1996, 72 days after receiving the submission on November 13, 1995. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number K955149 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 1995
Decision Date January 24, 1996
Days to Decision 72 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code BYY — Tube, Aspirating, Flexible, Connecting
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6740

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