The following data is part of a premarket notification filed by Coloplast Corp. with the FDA for Amoena Affinity Model #802.
| Device ID | K915382 |
| 510k Number | K915382 |
| Device Name: | AMOENA AFFINITY MODEL #802 |
| Classification | Prosthesis, Breast, External, Used With Adhesive |
| Applicant | COLOPLAST CORP. 2150 NEW MARKET PARKWAY, SUITE 116 Marietta, GA 30067 |
| Contact | Lee Lewis |
| Correspondent | Lee Lewis COLOPLAST CORP. 2150 NEW MARKET PARKWAY, SUITE 116 Marietta, GA 30067 |
| Product Code | KCZ |
| CFR Regulation Number | 878.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-29 |
| Decision Date | 1992-01-14 |