Almost U, Inc. Breast Prosthesis

FDA 510(k) K933668 · Almost U., Inc.

Substantially Equivalent

510(k) numberK933668

Submission

Device name
Almost U, Inc. Breast Prosthesis
Applicant
Almost U., Inc.
Peekskill, NY, US
Received
July 28, 1993
Decision date
December 10, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

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
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
K904085Ella Breast FormKCZ · Traditional Coloplast A/S10/31/1990SE
K904316Nouvelle (TM) Model #901, Sizes 0-12, Left & RightKCZ · Traditional Coloplast Corp.10/11/1990SE

Questions and answers

When was Almost U, Inc. Breast Prosthesis cleared by the FDA?

Almost U, Inc. Breast Prosthesis (K933668) received a 510(k) decision of Substantially Equivalent on December 10, 1993, 135 days after the submission was received.

What is the product code of K933668?

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