Cleared Traditional

K060109 - OMI RETRACTABLE SAFETY SYRINGE
(FDA 510(k) Clearance)

K060109 · Vitalcare Group, Inc. · General Hospital

May 2006

Decision

112d

Days

Class 2

Risk

K060109 is an FDA 510(k) clearance for the OMI RETRACTABLE SAFETY SYRINGE, a Syringe, Antistick (Class II — Special Controls, product code MEG), submitted by Vitalcare Group, Inc. (Deer Field, US). The FDA issued a Cleared decision on May 5, 2006, 112 days after receiving the submission on January 13, 2006. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number	K060109 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 13, 2006
Decision Date	May 05, 2006
Days to Decision	112 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF