Amoena Affinity Model #802
510(k) K915382
Amoena Affinity Model #802 is a Class I device made by Coloplast Corp., cleared under FDA 510(k) K915382 on 14 Jan 1992, active as of 11 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK915382 | Date14 Jan 1992 | StatusActive |
Official records
- FDA 510(k) database K915382
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KCZ
- Device class
- Class I
- Regulation
- 21 CFR Part 878.3800
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
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