SOL-GUARD INSULIN AND TUBERCULIN SAFETY SYRINGE

Syringe, Antistick

SOL-MILLENNIUM MEDICAL, INC.

The following data is part of a premarket notification filed by Sol-millennium Medical, Inc. with the FDA for Sol-guard Insulin And Tuberculin Safety Syringe.

Pre-market Notification Details

• Device ID: K132681
• 510k Number: K132681
• Device Name: SOL-GUARD INSULIN AND TUBERCULIN SAFETY SYRINGE
• Classification: Syringe, Antistick
• Applicant: SOL-MILLENNIUM MEDICAL, INC. 5415 SUGARLOAF PKWY, STE 2203 Lawrenceville, GA 30043
• Contact: Jim Barley
• Correspondent: Jim Barley; SOL-MILLENNIUM MEDICAL, INC. 5415 SUGARLOAF PKWY, STE 2203 Lawrenceville, GA 30043
• Product Code: MEG
• CFR Regulation Number: 880.5860 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-08-28
• Decision Date: 2014-05-22
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05903999600792	K132681	000
05903999600785	K132681	000
05903999600778	K132681	000
05903999600730	K132681	000
05903999600723	K132681	000
05903999600716	K132681	000
05903999600709	K132681	000
05903999600693	K132681	000
85903999600682	K132681	000