AMSure® Single Use Saline Topical Solution

Dressing, Wound, Drug

Amsino Medical Inc.

The following data is part of a premarket notification filed by Amsino Medical Inc. with the FDA for Amsure® Single Use Saline Topical Solution.

Pre-market Notification Details

• Device ID: K201138
• 510k Number: K201138
• Device Name: AMSure® Single Use Saline Topical Solution
• Classification: Dressing, Wound, Drug
• Applicant: Amsino Medical Inc. 700 Enterprise St. Aurora Aurora, IL 60504
• Contact: Torsten Nilson
• Correspondent: Torsten Nilson; Amsino Medical Inc. 700 Enterprise St. Aurora Aurora, IL 60504
• Product Code: FRO
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-04-28
• Decision Date: 2021-04-14