SUNTANA SUNBED #SB-1 & SUNBRELLA #SU-1
FDA 510(k) clearance K800744 · decided 1980-06-04
Clearance details
- K-number
- K800744
- Device name
- SUNTANA SUNBED #SB-1 & SUNBRELLA #SU-1
- Applicant
- Sun Ind., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-04-03
- Decision date
- 1980-06-04
- Days to decision
- 62 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
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Sun Ind.
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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.