Yours Truly Asymmetrical Breast Form
FDA 510(k) K911247 · Jobst Institute, Inc.
510(k) numberK911247
Submission
- Device name
- Yours Truly Asymmetrical Breast Form
- Applicant
- Jobst Institute, Inc.
Toledo, OH, US - Received
- March 21, 1991
- Decision date
- March 29, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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) | Device | Applicant | Decision |
|---|---|---|---|
| K990458 | Straumann Extraoral Implant SystemKCZ · Traditional | Straumann USA | 04/16/1999SE |
| K951324 | Maxol Image II Patient Matched Breast ProsthesisKCZ · Traditional | Maxol Limited L.C. | 05/26/1995SE |
| K933465 | CosmetKCZ · Traditional | Great Bay Medical Products, Inc. | 07/20/1994SE |
| K932978 | Calssique or MystiqueKCZ · Traditional | Dekumed, Kunststofftechnik Degler GmbH | 12/22/1993SE |
| K932899 | ClassiqueKCZ · Traditional | Hemispheres Marketing Co. , Ltd. | 12/16/1993SE |
| K933668 | Almost U, Inc. Breast ProsthesisKCZ · Traditional | Almost U., Inc. | 12/10/1993SE |
| K921535 | Suoena Affinity (TM) Model #802KCZ · Traditional | Coloplast Corp. | 05/11/1992SE |
| K915382 | Amoena Affinity Model #802KCZ · Traditional | Coloplast Corp. | 01/14/1992SE |
| K904085 | Ella Breast FormKCZ · Traditional | Coloplast A/S | 10/31/1990SE |
| K904316 | Nouvelle (TM) Model #901, Sizes 0-12, Left & RightKCZ · Traditional | Coloplast Corp. | 10/11/1990SE |
More from Coloplast Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K955138 | Anti-Em/Gp StockingsDWL · Traditional | 12/13/1995SE |
| K953763 | Gladiator Antishock PantsLHX · Traditional | 11/28/1995SE |
| K925583 | Jobskin Continuing CareMDA · Traditional | 04/04/1994SE |
| K925154 | Jobst-CustomDWL · Traditional | 04/04/1994SE |
| K934639 | Jobst Athrombic Pump - System 2500JOW · Traditional | 02/09/1994SE |
| K922681 | Cutinova FoamKMF · Traditional | 08/31/1992SE |
| K921562 | Jobst Extremity Pump System 7500JOW · Traditional | 06/22/1992SE |
| K920444 | UltimateDWL · Traditional | 04/20/1992SE |
| K912232 | UlcercareMCY · Traditional | 08/14/1991SE |
| K905631 | Comprinet, Comtesse and Bellavar StockingsDWL · Traditional | 03/07/1991SE |
Questions and answers
When was Yours Truly Asymmetrical Breast Form cleared by the FDA?
Yours Truly Asymmetrical Breast Form (K911247) received a 510(k) decision of Substantially Equivalent on March 29, 1991, 8 days after the submission was received.
What is the product code of K911247?
The FDA product code is KCZ – Prosthesis, Breast, External, Used With Adhesive, a Class I (low risk) device regulated under 21 CFR 878.3800.