SUNDASH
FDA 510(k) clearance K932483 · decided 1994-02-22
Clearance details
- K-number
- K932483
- Device name
- SUNDASH
- Applicant
- Sun Ind., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-05-24
- Decision date
- 1994-02-22
- Days to decision
- 274 days
- Clearance type
- Traditional
- Product code
- LEJ
- Device class
- 2
- Regulation number
- 878.4635
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Jonesboro, AR, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| SUN DASH RADIUS 252 PN 8000809705. The device is intended to be used for the tanning of hu recall (Z-2635-2014) | JK Products & Services, Inc | 2014-09-12 |