SOFT SOCK
FDA 510(k) clearance K944240 · decided 1994-12-27
Clearance details
- K-number
- K944240
- Device name
- SOFT SOCK
- Applicant
- Silipos, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-09-01
- Decision date
- 1994-12-27
- Days to decision
- 117 days
- Clearance type
- Traditional
- Product code
- FQL
- Device class
- 1
- Regulation number
- 880.5780
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Niagra Falls, NY, 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 |
|---|---|---|
| ELASTIC COMPRESSION ANKLET (K823789) | Orthopaedic Resources Corp. | 1983-01-07 |
| ELASTIC COMPRESSION ANKLET (K823350) | Podiatry Products Corp. | 1982-12-03 |
| VITASAN (K821259) | Selomas, Inc. | 1982-06-23 |
| VITOFIT (K821260) | Selomas, Inc. | 1982-06-23 |
| VENES CUSTON RX (K820484) | Jung Products, Inc. | 1982-03-18 |
Recalls involving this device
No recalls on record reference this clearance.