WING SAFE INFUSION SET 20 GA, SHS2000 SERIES; WING SAFE INFUSION SET 19 GA, SHS1900 SERIES; WING SAFE INFUSION SET 22 GA
FDA 510(k) clearance K020544 · decided 2002-03-12
Clearance details
- K-number
- K020544
- Device name
- WING SAFE INFUSION SET 20 GA, SHS2000 SERIES; WING SAFE INFUSION SET 19 GA, SHS1900 SERIES; WING SAFE INFUSION SET 22 GA
- Applicant
- Churchill Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-02-15
- Decision date
- 2002-03-12
- Days to decision
- 25 days
- Clearance type
- Special
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Dover, NH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Winged Infusion Set with 90 degree Huber Needle and Y Injection Site Distributed By: Flori recall (Z-1333-2011) | Churchill Medical Systems, Inc. | 2011-02-16 |