ERG-JET ELECTRODE— 510(k) K830557
Substantially EquivalentUniverso S.A.
FDA 510(k) clearance K830557 for ERG-JET ELECTRODE, Substantially Equivalent on 1983-03-31. Applicant: Universo S.A.. Device class: 2.
Clearance details
- Applicant
- Universo S.A.
- Product code
- Code HLZ
- Device class
- Class 2
- Regulation
- 21 CFR 886.1220
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
Recent devices under product code HLZ
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