The following data is part of a premarket notification filed by Coloplast Corp. with the FDA for Amoena Breast Forms.
| Device ID | K853822 |
| 510k Number | K853822 |
| Device Name: | AMOENA BREAST FORMS |
| Classification | Material, External Aesthetic Restoration, Used With Adhesive |
| Applicant | COLOPLAST CORP. 2150 NEW MARKET PARKWAY, SUITE 116 Marietta, GA 30067 |
| Contact | Thomas B Taylor |
| Correspondent | Thomas B Taylor COLOPLAST CORP. 2150 NEW MARKET PARKWAY, SUITE 116 Marietta, GA 30067 |
| Product Code | GBI |
| CFR Regulation Number | 878.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-13 |
| Decision Date | 1985-09-30 |