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Next General M20 Surgical Light +3 more models
FDA 510(k)Class II (US FDA 510(k))
510(k) K003489
Identifiers
- 510(k) Number
- K003489 FDA 510(k)
- FDA Product Code
- FSS FDA 510(k)
- Models / Variants
- Next General M20 Surgical Light FDA 510(k)Next Generation M16 Minor Surgery Light FDA 510(k)Next Generation Spotlight FDA 510(k)Next Generation M8 FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4580 FDA 510(k)
- Regulation Number
- 878.4580 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Next General M20 Surgical Light +3 more models by Medical Illumination International Inc. — Class II — FDA_510K — listed in FDA 510(k) — 4 models
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 | K003489 | Class II | Active |
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Manufacturer
- Manufacturer
- Medical Illumination International Inc.
- FDA Applicant
- Medical Illumination International, Inc.
Sources (1)
- FDA 510(k) K003489 24 fields · synced Jun 18, 2026