EndoSerter-PL— 510(k) K203586
Substantially EquivalentCorneagen, Inc.
FDA 510(k) clearance K203586 for EndoSerter-PL, Substantially Equivalent on 2022-02-02. Applicant: Corneagen, Inc.. Device class: 1.
Clearance details
- Applicant
- Corneagen, Inc.
- Product code
- Code OTZ
- Device class
- Class 1
- Regulation
- 21 CFR 886.4300
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Winston-Salem, NC, US
Recent devices under product code OTZ
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