COLLEXA

Dressing, Wound, Collagen

INNOCOLL PHARMACEUTICALS

The following data is part of a premarket notification filed by Innocoll Pharmaceuticals with the FDA for Collexa.

Pre-market Notification Details

• Device ID: K100574
• 510k Number: K100574
• Device Name: COLLEXA
• Classification: Dressing, Wound, Collagen
• Applicant: INNOCOLL PHARMACEUTICALS DUBLIN ROAD Athlone, Co. Westmeath, IE
• Contact: Aaron Wyse
• Correspondent: Aaron Wyse; INNOCOLL PHARMACEUTICALS DUBLIN ROAD Athlone, Co. Westmeath, IE
• Product Code: KGN
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-03-01
• Decision Date: 2010-10-28
• Summary: summary