Identifiers
- 510(k) Number
- K904316 FDA 510(k)
- FDA Product Code
- KCZ FDA 510(k)
- Models / Variants
- #901 FDA 510(k)Sizes 0-12 FDA 510(k)Left FDA 510(k)Right FDA 510(k)
Classification
- Device Class
- Class I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.3800 FDA 510(k)
- Regulation Number
- 878.3800 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Nouvelle (tm) (#901 +3 more) by Coloplast Corp. — Class I — FDA_510K — listed in FDA 510(k) — 4 models — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K904316 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Coloplast Corp.
Sources (1)
- FDA 510(k) K904316 24 fields · synced Jun 18, 2026