The following data is part of a premarket notification filed by Coloplast A/s with the FDA for Ella Breast Form.
| Device ID | K904085 |
| 510k Number | K904085 |
| Device Name: | ELLA BREAST FORM |
| Classification | Prosthesis, Breast, External, Used With Adhesive |
| Applicant | COLOPLAST A/S C/O RICHARD HAMER ASSOC., INC. P.O. BOX 16598 Ft. Worth, TX 76162 |
| Contact | Richard A Hamer |
| Correspondent | Richard A Hamer COLOPLAST A/S C/O RICHARD HAMER ASSOC., INC. P.O. BOX 16598 Ft. Worth, TX 76162 |
| Product Code | KCZ |
| CFR Regulation Number | 878.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-05 |
| Decision Date | 1990-10-31 |