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Medefil's Heparin I.v. Flush Syringe 1 Unit/Ml +2 more models
FDA 510(k)Class II (US FDA 510(k))
510(k) K092491
Identifiers
- 510(k) Number
- K092491 FDA 510(k)
- FDA Product Code
- NZW FDA 510(k)
- Models / Variants
- 10 Units/Ml FDA 510(k)And 100 Units/Ml In Various Fill Sizes FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5200 FDA 510(k)
- Regulation Number
- 880.5200 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Medefil's Heparin I.v. Flush Syringe 1 Unit/Ml +2 more models by Medefil, Inc. — Class II — FDA_510K — listed in FDA 510(k) — 3 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 | K092491 | Class II | Active |
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Manufacturer
- Manufacturer
- Medefil, Inc.
Sources (1)
- FDA 510(k) K092491 24 fields · synced Jun 19, 2026