GALAXY

Alloy, Gold-based Noble Metal

STERNGOLD

The following data is part of a premarket notification filed by Sterngold with the FDA for Galaxy.

Pre-market Notification Details

• Device ID: K003007
• 510k Number: K003007
• Device Name: GALAXY
• Classification: Alloy, Gold-based Noble Metal
• Applicant: STERNGOLD 23 FRANK MOSSBERG DR. Attleboro, MA 02703 -0967
• Contact: Susan L Spear
• Correspondent: Susan L Spear; STERNGOLD 23 FRANK MOSSBERG DR. Attleboro, MA 02703 -0967
• Product Code: EJT
• CFR Regulation Number: 872.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-09-26
• Decision Date: 2000-11-17

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00841549100062	K003007	000