Cleared Traditional

K061492 - MONOJECT MAGELLAN INSULIN AND TUBERCULIN SAFETY SYRINGE
(FDA 510(k) Clearance)

K061492 · Tyco Healthcare · General Hospital

Aug 2006

Decision

64d

Days

Class 2

Risk

K061492 is an FDA 510(k) clearance for the MONOJECT MAGELLAN INSULIN AND TUBERCULIN SAFETY SYRINGE. This device is classified as a Syringe, Piston (Class II — Special Controls, product code FMF).

Submitted by Tyco Healthcare (Mansfield, US). The FDA issued a Cleared decision on August 3, 2006, 64 days after receiving the submission on May 31, 2006.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number	K061492 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 31, 2006
Decision Date	August 03, 2006
Days to Decision	64 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF