DEKA PHYSIQ 360— 510(k) K231971
Substantially EquivalentEl.En S.P.A.
FDA 510(k) clearance K231971 for DEKA PHYSIQ 360, Substantially Equivalent on 2023-09-26. Applicant: El.En S.P.A.. Device class: 2.
Clearance details
- Applicant
- El.En S.P.A.
- Product code
- Code PKT
- Device class
- Class 2
- Regulation
- 21 CFR 878.5400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Calenzano, IT
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