LIFTLOC SAFETY INFUSION SET
FDA 510(k) clearance K013394 · decided 2001-11-08
Clearance details
- K-number
- K013394
- Device name
- LIFTLOC SAFETY INFUSION SET
- Applicant
- Specialized Health Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-10-15
- Decision date
- 2001-11-08
- Days to decision
- 24 days
- Clearance type
- Traditional
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Bountiful, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| SHPI LIftLoc Safety Infusion Sets recall (Z-0837-03) | Specialized Health Products, Inc. | 2003-05-15 |