KCZ — Prosthesis, Breast, External, Used With Adhesive Class I
FDA Device Classification
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 |