NEO IMPLANT SYSTEM

Implant, Endosseous, Root-form

NEOSS LTD

The following data is part of a premarket notification filed by Neoss Ltd with the FDA for Neo Implant System.

Pre-market Notification Details

• Device ID: K043195
• 510k Number: K043195
• Device Name: NEO IMPLANT SYSTEM
• Classification: Implant, Endosseous, Root-form
• Applicant: NEOSS LTD 719 A STREET NE Washington, DC 20002
• Contact: Russell Pagano
• Correspondent: Russell Pagano; NEOSS LTD 719 A STREET NE Washington, DC 20002
• Product Code: DZE
• CFR Regulation Number: 872.3640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-11-18
• Decision Date: 2005-03-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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