OMNIPORE SURGICAL IMPLANTS AND ACCESSORIES

Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction

MATRIX SURGICAL USA

The following data is part of a premarket notification filed by Matrix Surgical Usa with the FDA for Omnipore Surgical Implants And Accessories.

Pre-market Notification Details

• Device ID: K123908
• 510k Number: K123908
• Device Name: OMNIPORE SURGICAL IMPLANTS AND ACCESSORIES
• Classification: Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
• Applicant: MATRIX SURGICAL USA 111 LAUREL RIDGE DRIVE Alpharetta, GA 30004
• Contact: Julie Stephens
• Correspondent: Julie Stephens; MATRIX SURGICAL USA 111 LAUREL RIDGE DRIVE Alpharetta, GA 30004
• Product Code: KKY
• CFR Regulation Number: 878.3500 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-12-19
• Decision Date: 2013-07-31
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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