510(k) K060109

OMI RETRACTABLE SAFETY SYRINGE by Vitalcare Group, Inc. — Product Code MEG

K060109 is an FDA 510(k) premarket notification submitted by Vitalcare Group, Inc. for the device "OMI RETRACTABLE SAFETY SYRINGE". The FDA issued a decision of Substantially Equivalent on May 5, 2006. The device falls under product code MEG (Syringe, Antistick), a Class II device regulated under 21 CFR 880.5860. Vitalcare Group, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 2006
Date Received
January 13, 2006
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