LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8— 510(k) K070315
Substantially EquivalentLina Medical Aps
FDA 510(k) clearance K070315 for LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8, Substantially Equivalent on 2007-10-30. Applicant: Lina Medical Aps. Device class: 2.
Clearance details
- Applicant
- Lina Medical Aps
- Product code
- Product code KNF
- Device class
- Class 2
- Regulation
- 21 CFR 884.4160
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chapel Hill, NC, US
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