Cleared Traditional

CENTRAL VENOUS CATHETER DRESSING CHANGE TRAY

K912158 · Medical Device Inspection Co., Inc. · General Hospital

Oct 1991

Decision

160d

Days

Class 2

Risk

About This 510(k) Submission

K912158 is an FDA 510(k) clearance for the CENTRAL VENOUS CATHETER DRESSING CHANGE TRAY, a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II — Special Controls, product code FOZ), submitted by Medical Device Inspection Co., Inc. (Great Neck, US). The FDA issued a Cleared decision on October 23, 1991, 160 days after receiving the submission on May 16, 1991. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K912158 FDA.gov
FDA Decision	Cleared SESK
Date Received	May 16, 1991
Decision Date	October 23, 1991
Days to Decision	160 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement

Device Classification

Product Code	FOZ — Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5200