ELLA BREAST FORM
FDA 510(k) clearance K904085 · decided 1990-10-31
Clearance details
- K-number
- K904085
- Device name
- ELLA BREAST FORM
- Applicant
- Coloplast A/S
- Decision
- Substantially Equivalent
- Date received
- 1990-09-05
- Decision date
- 1990-10-31
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- KCZ
- Device class
- 1
- Regulation number
- 878.3800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Fort Woth, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| STRAUMANN EXTRAORAL IMPLANT SYSTEM (K990458) | Straumann USA | 1999-04-16 |
| MAXOL IMAGE II PATIENT MATCHED BREAST PROSTHESIS (K951324) | Maxol Limited L.C. | 1995-05-26 |
| COSMET (K933465) | Great Bay Medical Products, Inc. | 1994-07-20 |
| CALSSIQUE OR MYSTIQUE (K932978) | Dekumed, Kunststofftechnik Degler GmbH | 1993-12-22 |
| CLASSIQUE (K932899) | Hemispheres Marketing Co. , Ltd. | 1993-12-16 |
| ALMOST U, INC. BREAST PROSTHESIS (K933668) | Almost U., Inc. | 1993-12-10 |
| SUOENA AFFINITY (TM) MODEL #802 (K921535) | Coloplast Corp. | 1992-05-11 |
| AMOENA AFFINITY MODEL #802 (K915382) | Coloplast Corp. | 1992-01-14 |
| YOURS TRULY ASYMMETRICAL BREAST FORM (K911247) | Jobst Institute, Inc. | 1991-03-29 |
| NOUVELLE (TM) MODEL #901, SIZES 0-12, LEFT & RIGHT (K904316) | Coloplast Corp. | 1990-10-11 |
| DISCRENE SELF-SUPPORTING BREAST FORM (K904086) | Coloplast A/S | 1990-10-02 |
| SPENCO BREAST FORMS (K896533) | Spenco Medical Corp. | 1989-12-13 |
Recalls involving this device
No recalls on record reference this clearance.