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Advanced Computer Controlled Microkeratome-Accm, Model Surgical Instrument Syst…
FDA 510(k)Class I (US FDA 510(k))
510(k) K993190
Identifiers
- 510(k) Number
- K993190 FDA 510(k)
- FDA Product Code
- HNO FDA 510(k)
Classification
- Device Class
- Class I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.4370 FDA 510(k)
- Regulation Number
- 886.4370 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Advanced Computer Controlled Microkeratome-Accm, Model Surgical Instrument Syst… by Surgical Instrument Systems (Sis), Ltd. — Class I — FDA_510K — listed in…
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 | K993190 | Class I | Active |
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Manufacturer
- Manufacturer
- Surgical Instrument Systems (Sis), Ltd.
Sources (1)
- FDA 510(k) K993190 24 fields · synced Jun 18, 2026