FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
KENDALL-LTP TURNER SAVE-A-LINE
K Number: K003511
·
Decision Jan 24, 2001
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
13
Applicant Total
3
Review Days
71
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Basic Information
- Device Name
- KENDALL-LTP TURNER SAVE-A-LINE
- K Number
- K003511
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5680
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- The Ludlow Company LP
- Date Received
- November 14, 2000
- Decision Date
- January 24, 2001
- Product Code
- FRP
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FRP | Holder, Infant Position | FDA class 1 | General Hospital |
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