PDM, VILET, VILET QUICK, MONO Q, PLAIN GUT:# 6 CHROMIC GUT

Suture, Surgical, Absorbable, Polydioxanone

RIVERPOINT MEDICAL

The following data is part of a premarket notification filed by Riverpoint Medical with the FDA for Pdm, Vilet, Vilet Quick, Mono Q, Plain Gut:# 6 Chromic Gut.

Pre-market Notification Details

• Device ID: K100461
• 510k Number: K100461
• Device Name: PDM, VILET, VILET QUICK, MONO Q, PLAIN GUT:# 6 CHROMIC GUT
• Classification: Suture, Surgical, Absorbable, Polydioxanone
• Applicant: RIVERPOINT MEDICAL 825 NE 25TH AVE. Portland, OR 97232
• Contact: Doug Rowley
• Correspondent: Doug Rowley; RIVERPOINT MEDICAL 825 NE 25TH AVE. Portland, OR 97232
• Product Code: NEW
• CFR Regulation Number: 878.4840 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-02-18
• Decision Date: 2010-07-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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