Identifiers
- 510(k) Number
- K882280 FDA 510(k)
- FDA Product Code
- FXP FDA 510(k)
Classification
- Device Class
- Class I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4040 FDA 510(k)
- Regulation Number
- 878.4040 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Cover, Shoe Operating Room by A Plus International Inc. — Class I — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS
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 | K882280 | Class I | Active |
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Manufacturer
- Manufacturer
- A Plus International Inc.
- FDA Applicant
- A Plus International, Inc.
Sources (1)
- FDA 510(k) K882280 24 fields · synced Jun 18, 2026