ELASTOPLAST

Strip, Adhesive, Closure, Skin

BEIERSDORF, INC.

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

Pre-market Notification Details

• Device ID: K831438
• 510k Number: K831438
• Device Name: ELASTOPLAST
• Classification: Strip, Adhesive, Closure, Skin
• Applicant: BEIERSDORF, INC. 4221 Richmond Rd., N.W. Walker, MI 49534
• Product Code: FPX
• CFR Regulation Number: 880.5240 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1983-05-05
• Decision Date: 1983-11-25