Cleared Traditional

SUCTION TUBES: HOUSE, BARON

K892549 · Zinnanti Surgical Instruments, Inc. · General Hospital
May 1989
Decision
37d
Days
Class 2
Risk

About This 510(k) Submission

K892549 is an FDA 510(k) clearance for the SUCTION TUBES: HOUSE, BARON, a Apparatus, Suction, Operating-room, Wall Vacuum Powered (Class II — Special Controls, product code GCX), submitted by Zinnanti Surgical Instruments, Inc. (Chatsworth, US). The FDA issued a Cleared decision on May 18, 1989, 37 days after receiving the submission on April 11, 1989. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number K892549 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 1989
Decision Date May 18, 1989
Days to Decision 37 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code GCX — Apparatus, Suction, Operating-room, Wall Vacuum Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6740

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