KCZ — Prosthesis, Breast, External, Used With Adhesive Class I
FDA product code KCZ covers "Prosthesis, Breast, External, Used With Adhesive", a Class I medical device regulated under 21 CFR 878.3800. Submissions are reviewed by the General, Plastic Surgery panel. At least 13 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KCZ
- Device Class
- Class I
- Regulation Number
- 878.3800
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K990458 | straumann usa | STRAUMANN EXTRAORAL IMPLANT SYSTEM | April 16, 1999 |
| K951324 | maxol limited l.c | MAXOL IMAGE II PATIENT MATCHED BREAST PROSTHESIS | May 26, 1995 |
| K933465 | great bay medical products | COSMET | July 20, 1994 |
| K932978 | dekumed, kunststofftechnik degler | CALSSIQUE OR MYSTIQUE | December 22, 1993 |
| K932899 | hemispheres marketing co. | CLASSIQUE | December 16, 1993 |
| K933668 | almost u | ALMOST U, INC. BREAST PROSTHESIS | December 10, 1993 |
| K921535 | coloplast | SUOENA AFFINITY (TM) MODEL #802 | May 11, 1992 |
| K915382 | coloplast | AMOENA AFFINITY MODEL #802 | January 14, 1992 |
| K911247 | jobst institute | YOURS TRULY ASYMMETRICAL BREAST FORM | March 29, 1991 |
| K904085 | coloplast | ELLA BREAST FORM | October 31, 1990 |
| K904316 | coloplast | NOUVELLE (TM) MODEL #901, SIZES 0-12, LEFT & RIGHT | October 11, 1990 |
| K904086 | coloplast | DISCRENE SELF-SUPPORTING BREAST FORM | October 2, 1990 |
| K896533 | spenco medical | SPENCO BREAST FORMS | December 13, 1989 |