Cleared Traditional

PUSH-ON NEEDLE 30GX8MM

K120191 · Scandinavian Health Limited · General Hospital

May 2012

Decision

121d

Days

Class 2

Risk

About This 510(k) Submission

K120191 is an FDA 510(k) clearance for the PUSH-ON NEEDLE 30GX8MM, a Needle, Hypodermic, Single Lumen (Class II — Special Controls, product code FMI), submitted by Scandinavian Health Limited (Taoyuan City, TW). The FDA issued a Cleared decision on May 23, 2012, 121 days after receiving the submission on January 23, 2012. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number	K120191 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 23, 2012
Decision Date	May 23, 2012
Days to Decision	121 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF