VYGON LEADER-FLEX
FDA 510(k) clearance K052564 · decided 2006-04-05
Clearance details
- K-number
- K052564
- Device name
- VYGON LEADER-FLEX
- Applicant
- Vygon Corp.
- Decision
- Substantially Equivalent
- Date received
- 2005-09-19
- Decision date
- 2006-04-05
- Days to decision
- 198 days
- Clearance type
- Traditional
- Product code
- FOZ
- Device class
- 2
- Regulation number
- 880.5200
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Norristown, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.