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MEDEFIL'S NORMAL SALINE FLUSH SYRINGE, IN VARIOUS FILL SIZES - 1 ML FILL IN 3 ML SYRINGE LL - 1 Ml Fill In 6 Ml Syringe L
FDA 510(k)Class II (US FDA 510(k))
510(k) K993515
Identifiers
- 510(k) Number
- K993515 FDA 510(k)
- FDA Product Code
- FOZ FDA 510(k)
- Models / Variants
- Medefil's Normal Saline Flush Syringe, In Various Fill Sizes - 1 Ml Fill In 3 Ml Syringe Ll FDA 510(k)1 Ml Fill In 6 Ml Syringe L 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 NORMAL SALINE FLUSH SYRINGE, IN VARIOUS FILL SIZES - 1 ML FILL IN 3 ML SYRINGE LL - 1 Ml Fill In 6 Ml Syringe L by Medefil, Inc. — Class II…
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 | K993515 | Class II | Active |
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Manufacturer
- Manufacturer
- Medefil, Inc.
Sources (1)
- FDA 510(k) K993515 24 fields · synced Jun 18, 2026