510(k) K140949

ULTICARE SAFETY SYRINGE WITH REMOVABLE NEEDLE by Ultimed Incorporated — Product Code MEG

K140949 is an FDA 510(k) premarket notification submitted by Ultimed Incorporated for the device "ULTICARE SAFETY SYRINGE WITH REMOVABLE NEEDLE". The FDA issued a decision of Substantially Equivalent on Feb 9, 2015. The device falls under product code MEG (Syringe, Antistick), a Class II device regulated under 21 CFR 880.5860. Ultimed Incorporated has 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Feb 9, 2015
Date Received
Apr 14, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Antistick
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type
510(k)