FUSION SYSTEM— 510(k) K093465
Substantially EquivalentEclipsemed Global, Inc.
FDA 510(k) clearance K093465 for FUSION SYSTEM, Substantially Equivalent on 2010-01-05. Applicant: Eclipsemed Global, Inc.. Device class: 2.
Clearance details
- Applicant
- Eclipsemed Global, Inc.
- 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
- Dallas, TX, US
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