Ella Breast Form

FDA 510(k) K904085 · Coloplast A/S

Substantially Equivalent

510(k) numberK904085

Submission

Device name
Ella Breast Form
Applicant
Coloplast A/S
Fort Woth, TX, US
Received
September 5, 1990
Decision date
October 31, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KCZ – Prosthesis, Breast, External, Used With Adhesive
Device class
Class I (low risk)
Regulation
21 CFR 878.3800
Specialty
General, Plastic Surgery

Other 510(k)s with product code KCZ

510(k)DeviceApplicantDecision
K990458Straumann Extraoral Implant SystemKCZ · Traditional Straumann USA04/16/1999SE
K951324Maxol Image II Patient Matched Breast ProsthesisKCZ · Traditional Maxol Limited L.C.05/26/1995SE
K933465CosmetKCZ · Traditional Great Bay Medical Products, Inc.07/20/1994SE
K932978Calssique or MystiqueKCZ · Traditional Dekumed, Kunststofftechnik Degler GmbH12/22/1993SE
K932899ClassiqueKCZ · Traditional Hemispheres Marketing Co. , Ltd.12/16/1993SE
K933668Almost U, Inc. Breast ProsthesisKCZ · Traditional Almost U., Inc.12/10/1993SE
K921535Suoena Affinity (TM) Model #802KCZ · Traditional Coloplast Corp.05/11/1992SE
K915382Amoena Affinity Model #802KCZ · Traditional Coloplast Corp.01/14/1992SE
K911247Yours Truly Asymmetrical Breast FormKCZ · Traditional Jobst Institute, Inc.03/29/1991SE
K904316Nouvelle (TM) Model #901, Sizes 0-12, Left & RightKCZ · Traditional Coloplast Corp.10/11/1990SE

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K140310Peristeen Anal Irrigation SystemKNT · Traditional 09/03/2015SE
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Questions and answers

When was Ella Breast Form cleared by the FDA?

Ella Breast Form (K904085) received a 510(k) decision of Substantially Equivalent on October 31, 1990, 56 days after the submission was received.

What is the product code of K904085?

The FDA product code is KCZ – Prosthesis, Breast, External, Used With Adhesive, a Class I (low risk) device regulated under 21 CFR 878.3800.