Cleared Traditional

K960982 - MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT I.V. ACCESS CANNULA
(FDA 510(k) Clearance)

K960982 · Sherwood Medical Co. · General Hospital

Dec 1996

Decision

287d

Days

Class 2

Risk

K960982 is an FDA 510(k) clearance for the MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT I.V. ACCESS CANNULA, a Needle, Hypodermic, Single Lumen (Class II — Special Controls, product code FMI), submitted by Sherwood Medical Co. (St. Louis, US). The FDA issued a Cleared decision on December 23, 1996, 287 days after receiving the submission on March 11, 1996. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number	K960982 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 11, 1996
Decision Date	December 23, 1996
Days to Decision	287 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF