ELASTOPLAST

Tape And Bandage, Adhesive

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: K904500
• 510k Number: K904500
• Device Name: ELASTOPLAST
• Classification: Tape And Bandage, Adhesive
• Applicant: BEIERSDORF, INC. 360 MARTIN LUTHER KING DR. P.O. BOX 5529 Norwalk, CT 06856
• Contact: Vincent Vilano
• Correspondent: Vincent Vilano; BEIERSDORF, INC. 360 MARTIN LUTHER KING DR. P.O. BOX 5529 Norwalk, CT 06856
• Product Code: KGX
• CFR Regulation Number: 880.5240 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1990-10-02
• Decision Date: 1990-11-21