SUNBED/SUNROOF OR SUNCOUCH/SUNSKY— 510(k) K801542
Substantially EquivalentSunfit, Inc.
FDA 510(k) clearance K801542 for SUNBED/SUNROOF OR SUNCOUCH/SUNSKY, Substantially Equivalent on 1980-08-20. Applicant: Sunfit, Inc.. Device class: 2.
Clearance details
- Applicant
- Sunfit, 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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view allData sourced from openFDA. This site is unofficial and independent of the FDA.