SUN SCIENTIFIC LLC-LEG COMPRESSOR AND PFAB
FDA 510(k) clearance K070457 · decided 2007-05-16
Clearance details
- K-number
- K070457
- Device name
- SUN SCIENTIFIC LLC-LEG COMPRESSOR AND PFAB
- Applicant
- Sun Scientific, LLC
- Decision
- Substantially Equivalent
- Date received
- 2007-02-16
- Decision date
- 2007-05-16
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- MHW
- Device class
- 1
- Regulation number
- 880.5075
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Shelton, CT, 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.
| Record | Firm | Date |
|---|---|---|
| STASIS BUTTON PRSSURE DEVICE (K912765) | Arch Development Group | 1991-08-12 |
Recalls involving this device
No recalls on record reference this clearance.