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HYDRAGEL ISO-PAL K20 - Hydragel 7 Iso-Pal (pn 4112)
FDA 510(k)Class II (US FDA 510(k))
510(k) K011113
by Sebia
Identifiers
- 510(k) Number
- K011113 FDA 510(k)
- FDA Product Code
- CIN FDA 510(k)
- Models / Variants
- Hydragel Iso-Pal K20 (pn 3022) FDA 510(k)Hydragel 7 Iso-Pal (pn 4112) FDA 510(k)Hydragel 15 Iso-Pal (pn 4132) FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1050 FDA 510(k)
- Regulation Number
- 862.1050 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
HYDRAGEL ISO-PAL K20 - Hydragel 7 Iso-Pal (pn 4112) by Sebia — Class II — FDA_510K — listed in FDA 510(k) — 3 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 | K011113 | Class II | Active |
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Manufacturer
- Manufacturer
- Sebia
Sources (1)
- FDA 510(k) K011113 24 fields · synced Jun 18, 2026