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A.o. Synthes, Tap(replacement)various Model Numbers
FDA 510(k)Class I (US FDA 510(k))
510(k) K904949
Identifiers
- 510(k) Number
- K904949 FDA 510(k)
- FDA Product Code
- HSZ FDA 510(k)
Classification
- Device Class
- Class I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4820 FDA 510(k)
- Regulation Number
- 878.4820 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
A.o. Synthes, Tap(replacement)various Model Numbers by MicroAire Surgical Instruments LLC — Class I — 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 | K904949 | Class I | Active |
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Manufacturer
- Manufacturer
- MicroAire Surgical Instruments LLC
- FDA Applicant
- Micro-Aire Surgical Instruments, Inc.
Sources (1)
- FDA 510(k) K904949 24 fields · synced Jun 18, 2026