FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8
K Number: K070315
·
Decision Oct 30, 2007
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
43
Applicant Total
16
Review Days
271
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Basic Information
- Device Name
- LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8
- K Number
- K070315
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4160
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lina Medical Aps
- Date Received
- February 1, 2007
- Decision Date
- October 30, 2007
- Product Code
- KNF
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| KNF | Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | FDA class 2 | Obstetrics/Gynecology |
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