KANGAROO(R) 524 ENTERAL FEEDING PUMP AND ADMINISTRATION SETS
FDA 510(k) clearance K945964 · decided 1995-03-07
Clearance details
- K-number
- K945964
- Device name
- KANGAROO(R) 524 ENTERAL FEEDING PUMP AND ADMINISTRATION SETS
- Applicant
- Sherwood Medical Co.
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Date received
- 1994-12-07
- Decision date
- 1995-03-07
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- LZH
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- St. Joseph, MO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.