MINISILK FT— 510(k) K082040
Substantially EquivalentEl.En Electronic Engineering Spa
FDA 510(k) clearance K082040 for MINISILK FT, Substantially Equivalent on 2009-08-27. Applicant: El.En Electronic Engineering Spa. Device class: 2.
Clearance details
- Applicant
- El.En Electronic Engineering Spa
- Product code
- Code ONF
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Calenzano, IT
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