CURAD SCAR THERAPY

Elastomer, Silicone, For Scar Management

BEIERSDORF, INC.

The following data is part of a premarket notification filed by Beiersdorf, Inc. with the FDA for Curad Scar Therapy.

Pre-market Notification Details

• Device ID: K024057
• 510k Number: K024057
• Device Name: CURAD SCAR THERAPY
• Classification: Elastomer, Silicone, For Scar Management
• Applicant: BEIERSDORF, INC. 700 THIRTEENTH STREET, N.W. SUITE 1200 Washington, DC 20005 -5929
• Contact: Frances K Wu
• Correspondent: Frances K Wu; BEIERSDORF, INC. 700 THIRTEENTH STREET, N.W. SUITE 1200 Washington, DC 20005 -5929
• Product Code: MDA
• CFR Regulation Number: 878.4025 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: Yes
• Date Received: 2002-12-09
• Decision Date: 2003-06-18
• Summary: summary