MERRITTAN SUN SYSTEM
FDA 510(k) clearance K834488 · decided 1984-02-09
Clearance details
- K-number
- K834488
- Device name
- MERRITTAN SUN SYSTEM
- Applicant
- Interfit A.G. Dba/Int'L Tanning Sys
- Decision
- Substantially Equivalent
- Date received
- 1983-12-14
- Decision date
- 1984-02-09
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- FTC
- Device class
- 2
- Regulation number
- 878.4630
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.