PERFECT ONE

Alloy, Metal, Base

NORTH AMERICAN ALLOYS, INC.

The following data is part of a premarket notification filed by North American Alloys, Inc. with the FDA for Perfect One.

Pre-market Notification Details

• Device ID: K862930
• 510k Number: K862930
• Device Name: PERFECT ONE
• Classification: Alloy, Metal, Base
• Applicant: NORTH AMERICAN ALLOYS, INC. 225 BRENTWOOD CT. Bloomingdale, IL 60108
• Contact: Kathleen Calero
• Correspondent: Kathleen Calero; NORTH AMERICAN ALLOYS, INC. 225 BRENTWOOD CT. Bloomingdale, IL 60108
• Product Code: EJH
• CFR Regulation Number: 872.3710 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1986-08-04
• Decision Date: 1986-10-24