Cleared Traditional

CURITY THORACENTESIS TRAY

K964519 · Kendall Healthcare Products Co. Div.Of Tyco Health · General Hospital
Dec 1996
Decision
38d
Days
Class 2
Risk

About This 510(k) Submission

K964519 is an FDA 510(k) clearance for the CURITY THORACENTESIS TRAY, a Apparatus, Suction, Operating-room, Wall Vacuum Powered (Class II — Special Controls, product code GCX), submitted by Kendall Healthcare Products Co. Div.Of Tyco Health (Mansfield, US). The FDA issued a Cleared decision on December 20, 1996, 38 days after receiving the submission on November 12, 1996. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number K964519 FDA.gov
FDA Decision Cleared SESE
Date Received November 12, 1996
Decision Date December 20, 1996
Days to Decision 38 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

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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