Cleared Traditional

TSK STERIJEKT PREMIUM DISPOSABLE HYPODERMIC NEEDLE

K970370 · Tsk Laboratory, Japan · General Hospital

Apr 1997

Decision

69d

Days

Class 2

Risk

About This 510(k) Submission

K970370 is an FDA 510(k) clearance for the TSK STERIJEKT PREMIUM DISPOSABLE HYPODERMIC NEEDLE, a Needle, Hypodermic, Single Lumen (Class II — Special Controls, product code FMI), submitted by Tsk Laboratory, Japan (Tochigi-Shi, Tochigi-Ken, JP). The FDA issued a Cleared decision on April 10, 1997, 69 days after receiving the submission on January 31, 1997. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number	K970370 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 31, 1997
Decision Date	April 10, 1997
Days to Decision	69 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF