Curad

FDA 510(k) K022645 · Beiersdorf AG

Substantially Equivalent

510(k) numberK022645

Submission

Device name
Curad
Applicant
Beiersdorf AG
North Attleboro, MA, US
Received
August 8, 2002
Decision date
November 5, 2002
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KMF – Bandage, Liquid
Device class
Class I (low risk)
Regulation
21 CFR 880.5090
Specialty
General Hospital

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More from Polichem S.A

510(k)DeviceDecision
K090921Anti-Embolism Stockings, Models 71055-00000-02, 71057-00000-02, 71059-00000-02…DWL · Traditional 12/18/2009SE
K032463Curad Silver BandageFRO · Traditional 02/10/2004SE
K032462Curad Silver Active Gel BandageFRO · Traditional 02/10/2004SE
K024057Curad Scar TherapyMDA · Traditional 06/18/2003SE
K952526Cutinova CavityKMF · Traditional 08/14/1995SN
K943363Cutiplast SterilMGP · Traditional 03/15/1995SE
K944581Cutinova Thin Wound DressingKMF · Traditional 12/02/1994SN
K935630NortaEZL · Traditional 10/07/1994SE
K940378Coverlet Adhesive DressingKGX · Traditional 07/29/1994SN
K925630Elastoplast Heat PlasterIRT · Traditional 02/25/1994SE

Questions and answers

When was Curad cleared by the FDA?

Curad (K022645) received a 510(k) decision of Substantially Equivalent on November 5, 2002, 89 days after the submission was received.

What is the product code of K022645?

The FDA product code is KMF – Bandage, Liquid, a Class I (low risk) device regulated under 21 CFR 880.5090.