FDA Product Code
FDA Product Code KCZ — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.3800
510(k) Clearances — 13 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K990458 | STRAUMANN EXTRAORAL IMPLANT SYSTEM | Straumann USA | 1999-04-16 | Traditional | PDF ↗ |
| K951324 | MAXOL IMAGE II PATIENT MATCHED BREAST PROSTHESIS | Maxol Limited L.C. | 1995-05-26 | Traditional | PDF ↗ |
| K933465 | COSMET | Great Bay Medical Products, Inc. | 1994-07-20 | Traditional | PDF ↗ |
| K932978 | CALSSIQUE OR MYSTIQUE | Dekumed, Kunststofftechnik Degler GmbH | 1993-12-22 | Traditional | PDF ↗ |
| K932899 | CLASSIQUE | Hemispheres Marketing Co. , Ltd. | 1993-12-16 | Traditional | PDF ↗ |
| K933668 | ALMOST U, INC. BREAST PROSTHESIS | Almost U., Inc. | 1993-12-10 | Traditional | PDF ↗ |
| K921535 | SUOENA AFFINITY (TM) MODEL #802 | Coloplast Corp. | 1992-05-11 | Traditional | PDF ↗ |
| K915382 | AMOENA AFFINITY MODEL #802 | Coloplast Corp. | 1992-01-14 | Traditional | PDF ↗ |
| K911247 | YOURS TRULY ASYMMETRICAL BREAST FORM | Jobst Institute, Inc. | 1991-03-29 | Traditional | PDF ↗ |
| K904085 | ELLA BREAST FORM | Coloplast A/S | 1990-10-31 | Traditional | PDF ↗ |
| K904316 | NOUVELLE (TM) MODEL #901, SIZES 0-12, LEFT & RIGHT | Coloplast Corp. | 1990-10-11 | Traditional | PDF ↗ |
| K904086 | DISCRENE SELF-SUPPORTING BREAST FORM | Coloplast A/S | 1990-10-02 | Traditional | PDF ↗ |
| K896533 | SPENCO BREAST FORMS | Spenco Medical Corp. | 1989-12-13 | Traditional | PDF ↗ |
Product code KCZ · Class I · General, Plastic Surgery. Data: openFDA.