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TUMARK PROFESSIONAL - Tumark Professional, Model 271560
FDA 510(k)Class II (US FDA 510(k))
510(k) K073095
Identifiers
- 510(k) Number
- K073095 FDA 510(k)
- FDA Product Code
- NEU FDA 510(k)
- Models / Variants
- Tumark Professional, Model 271560 FDA 510(k)Mr- Tumark Professional, Model 601560 FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4300 FDA 510(k)
- Regulation Number
- 878.4300 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
TUMARK PROFESSIONAL - Tumark Professional, Model 271560 by SOMATEX Medical Technologies GmbH — Class II — FDA_510K — listed in FDA 510(k) — 2 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 | K073095 | Class II | Active |
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Manufacturer
- Manufacturer
- SOMATEX Medical Technologies GmbH
Sources (1)
- FDA 510(k) K073095 24 fields · synced Jun 18, 2026