CONFORMA

Material, External Aesthetic Restoration, Used With Adhesive

BEIERSDORF, INC.

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

Pre-market Notification Details

• Device ID: K841559
• 510k Number: K841559
• Device Name: CONFORMA
• Classification: Material, External Aesthetic Restoration, Used With Adhesive
• Applicant: BEIERSDORF, INC. 4221 Richmond Rd., N.W. Walker, MI 49534
• Product Code: GBI
• CFR Regulation Number: 878.3800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1984-04-16
• Decision Date: 1984-07-17