Suoena Affinity (TM) Model #802
FDA 510(k) K921535 · Coloplast Corp.
510(k) numberK921535
Submission
- Device name
- Suoena Affinity (TM) Model #802
- Applicant
- Coloplast Corp.
Marietta, GA, US - Received
- March 31, 1992
- Decision date
- May 11, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| K915382 | Amoena Affinity Model #802KCZ · Traditional | Coloplast Corp. | 01/14/1992SE |
| K911247 | Yours Truly Asymmetrical Breast FormKCZ · Traditional | Jobst Institute, Inc. | 03/29/1991SE |
| 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 |
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| K242473 | Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551)…PAH · Traditional | 10/18/2024SE |
| K241028 | Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056)EZD · Traditional | 07/26/2024SE |
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Questions and answers
When was Suoena Affinity (TM) Model #802 cleared by the FDA?
Suoena Affinity (TM) Model #802 (K921535) received a 510(k) decision of Substantially Equivalent on May 11, 1992, 41 days after the submission was received.
What is the product code of K921535?
The FDA product code is KCZ – Prosthesis, Breast, External, Used With Adhesive, a Class I (low risk) device regulated under 21 CFR 878.3800.