Cleared Traditional

K072739 - JIERUI SYRINGES AND NEEDLES (FDA 510(k) Clearance)

Mar 2008
Decision
176d
Days
Class 2
Risk

K072739 is an FDA 510(k) clearance for the JIERUI SYRINGES AND NEEDLES. This device is classified as a Syringe, Antistick (Class II - Special Controls, product code MEG).

Submitted by Shandong Weigao Group Medical Polymer Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on March 21, 2008, 176 days after receiving the submission on September 27, 2007.

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

Submission Details

510(k) Number K072739 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2007
Decision Date March 21, 2008
Days to Decision 176 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code MEG - Syringe, Antistick
Device Class Class II - Special Controls
CFR Regulation 21 CFR 880.5860