PERFECT 10

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 10.

Pre-market Notification Details

• Device ID: K853498
• 510k Number: K853498
• Device Name: PERFECT 10
• Classification: Alloy, Metal, Base
• Applicant: NORTH AMERICAN ALLOYS, INC. 225 BRENTWOOD CT. Bloomingdale, IL 60108
• Contact: Manny Calero
• Correspondent: Manny 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: 1985-08-20
• Decision Date: 1985-09-27