EM-4000 Specular Microscope— 510(k) K171313
Substantially EquivalentTomey Corporation
FDA 510(k) clearance K171313 for EM-4000 Specular Microscope, Substantially Equivalent on 2018-01-19. Applicant: Tomey Corporation. Device class: 2.
Clearance details
- Applicant
- Tomey Corporation
- Product code
- Code NQE
- Device class
- Class 2
- Regulation
- 21 CFR 886.1850
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Nagoya, JP
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