SOLAR TONE— 510(k) K802304
Substantially EquivalentBloomex International, Inc.
FDA 510(k) clearance K802304 for SOLAR TONE, Substantially Equivalent on 1980-12-01. Applicant: Bloomex International, Inc.. Device class: 2.
Clearance details
- Applicant
- Bloomex International, Inc.
- Product code
- Code LEJ
- Device class
- Class 2
- Regulation
- 21 CFR 878.4635
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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