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Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G)…
FDA 510(k)Class II (US FDA 510(k))
510(k) K231124
Identifiers
- 510(k) Number
- K231124 FDA 510(k)
- FDA Product Code
- FMK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4850 FDA 510(k)
- Regulation Number
- 878.4850 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G)… by Owen Mumford Ltd — Class II — FDA_510K — listed in FDA 510(k)
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 | K231124 | Class II | Active |
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Manufacturer
- Manufacturer
- Owen Mumford Ltd
- FDA Applicant
- Owen Mumford, Ltd.
Sources (1)
- FDA 510(k) K231124 24 fields · synced Jun 19, 2026