510(k) K132681

SOL-GUARD INSULIN AND TUBERCULIN SAFETY SYRINGE by Sol-Millennium Medical, Inc. — Product Code MEG

K132681 is an FDA 510(k) premarket notification submitted by Sol-Millennium Medical, Inc. for the device "SOL-GUARD INSULIN AND TUBERCULIN SAFETY SYRINGE". The FDA issued a decision of Substantially Equivalent on May 22, 2014. 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
May 22, 2014
Date Received
August 28, 2013
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