STATSTIX

Cord, Retraction

Centrix Incorporated

The following data is part of a premarket notification filed by Centrix Incorporated with the FDA for Statstix.

Pre-market Notification Details

• Device ID: K200764
• 510k Number: K200764
• Device Name: STATSTIX
• Classification: Cord, Retraction
• Applicant: Centrix Incorporated 770 River Road Shelton, CT 06484
• Contact: Greg Moreau
• Correspondent: Roger S Mastrony; MedTek LLC 2516 Kettle Creek Court Lincolnton, NC 28092
• Product Code: MVL
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-03-24
• Decision Date: 2020-10-15

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00817051022970	K200764	000
00817051022963	K200764	000