510(k) K103011

ULTICARE SAFETY INSULIN SYRINGE by Ulti-Med Intl., Inc. — Product Code MEG

K103011 is an FDA 510(k) premarket notification submitted by Ulti-Med Intl., Inc. for the device "ULTICARE SAFETY INSULIN SYRINGE". The FDA issued a decision of Substantially Equivalent on February 2, 2011. The device falls under product code MEG (Syringe, Antistick), a Class II device regulated under 21 CFR 880.5860. Ulti-Med Intl., Inc. has at least 10 other 510(k) clearances on record.