K853822 is an FDA 510(k) clearance for the AMOENA BREAST FORMS. This device is classified as a Material, External Aesthetic Restoration, Used With Adhesive (Class I - General Controls, product code GBI).
Submitted by Coloplast Corp. (Marietta, US). The FDA issued a Cleared decision on September 30, 1985, 17 days after receiving the submission on September 13, 1985.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3800.
| 510(k) Number | K853822 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 13, 1985 |
| Decision Date | September 30, 1985 |
| Days to Decision | 17 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GBI — Material, External Aesthetic Restoration, Used With Adhesive |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.3800 |