MONORAIL

Implant, Endosseous, Root-form

NATS CORP.

The following data is part of a premarket notification filed by Nats Corp. with the FDA for Monorail.

Pre-market Notification Details

• Device ID: K040143
• 510k Number: K040143
• Device Name: MONORAIL
• Classification: Implant, Endosseous, Root-form
• Applicant: NATS CORP. 30 NORTHPORT RD. Sound Beach, NY 11789 -1734
• Contact: Richard Lanzillotto
• Correspondent: Richard Lanzillotto; NATS CORP. 30 NORTHPORT RD. Sound Beach, NY 11789 -1734
• Product Code: DZE
• CFR Regulation Number: 872.3640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-01-22
• Decision Date: 2004-09-13