510(k) K162030

0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle by Sol-Millennium Medical, Inc. — Product Code MEG

K162030 is an FDA 510(k) premarket notification submitted by Sol-Millennium Medical, Inc. for the device "0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle". The FDA issued a decision of Substantially Equivalent on August 19, 2016. The device falls under product code MEG (Syringe, Antistick), a Class II device regulated under 21 CFR 880.5860. Sol-Millennium Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 2016
Date Received
July 22, 2016
Clearance Type
Special
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