MONOTEX

Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene

RIVERPOINT MEDICAL

The following data is part of a premarket notification filed by Riverpoint Medical with the FDA for Monotex.

Pre-market Notification Details

• Device ID: K140415
• 510k Number: K140415
• Device Name: MONOTEX
• Classification: Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
• Applicant: RIVERPOINT MEDICAL 825 NE 25TH AVE. Portland, OR 97232
• Contact: Douglas Rowley
• Correspondent: Douglas Rowley; RIVERPOINT MEDICAL 825 NE 25TH AVE. Portland, OR 97232
• Product Code: NBY
• CFR Regulation Number: 878.5035 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-02-18
• Decision Date: 2014-03-26
• Summary: summary