Cleared Traditional

PLATYPUS AV FISTULA NEEDLE PROTECTOR (AVFNP)

K991404 · Itl Corporation Pty, Ltd. · General Hospital

May 1999

Decision

22d

Days

Class 2

Risk

About This 510(k) Submission

K991404 is an FDA 510(k) clearance for the PLATYPUS AV FISTULA NEEDLE PROTECTOR (AVFNP), a Needle, Hypodermic, Single Lumen (Class II — Special Controls, product code FMI), submitted by Itl Corporation Pty, Ltd. (Rockville, US). The FDA issued a Cleared decision on May 14, 1999, 22 days after receiving the submission on April 22, 1999. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number	K991404 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 22, 1999
Decision Date	May 14, 1999
Days to Decision	22 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF