SUNSATION
FDA 510(k) clearance K801429 · decided 1980-07-28
Clearance details
- K-number
- K801429
- Device name
- SUNSATION
- Applicant
- Fashion, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-06-17
- Decision date
- 1980-07-28
- Days to decision
- 41 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
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.