NEOSALUS

Dressing, Wound, Drug

QUINNOVA PHARMACEUTICALS

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

Pre-market Notification Details

• Device ID: K070309
• 510k Number: K070309
• Device Name: NEOSALUS
• Classification: Dressing, Wound, Drug
• Applicant: QUINNOVA PHARMACEUTICALS 301SOUTH STATE STREET SUITE NOO1 Newtown, PA 18940
• Contact: Jeffrey Day
• Correspondent: Jeffrey Day; QUINNOVA PHARMACEUTICALS 301SOUTH STATE STREET SUITE NOO1 Newtown, PA 18940
• Product Code: FRO
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: Yes
• Date Received: 2007-02-01
• Decision Date: 2008-09-12
• Summary: summary