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Dale(r) Nasal Dressing Holder (product No. 600)
FDA 510(k)EUDAMEDClass I (US FDA 510(k))
510(k) K914245
Identifiers
- 510(k) Number
- K914245 FDA 510(k)
- FDA Product Code
- KGX FDA 510(k)
Classification
- Device Class
- Class I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5240 FDA 510(k)
- Regulation Number
- 880.5240 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Dale(r) Nasal Dressing Holder (product No. 600) by Dale Medical Products, Inc. — Class I — MDR, FDA_510K — listed in FDA 510(k), EUDAMED
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
MDR
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K914245 | Class I | Active |
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Manufacturer
- Manufacturer
- Dale Medical Products, Inc.
Sources (2)
- FDA 510(k) K914245 24 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced May 19, 2026