STERNGOLD U-CPF METAL ALLOY (1067800)

Alloy, Other Noble Metal

STERNGOLD/IMPLAMED

The following data is part of a premarket notification filed by Sterngold/implamed with the FDA for Sterngold U-cpf Metal Alloy (1067800).

Pre-market Notification Details

• Device ID: K962324
• 510k Number: K962324
• Device Name: STERNGOLD U-CPF METAL ALLOY (1067800)
• Classification: Alloy, Other Noble Metal
• Applicant: STERNGOLD/IMPLAMED 23 FRANK MOSSBERG DR. Attleboro, MA 02703 -0967
• Product Code: EJS
• CFR Regulation Number: 872.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-06-17
• Decision Date: 1996-07-24

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00841549100147	K962324	000