INSUFLOW DEVICE, MODEL 6198
FDA 510(k) clearance K063546 · decided 2007-01-10
Clearance details
- K-number
- K063546
- Device name
- INSUFLOW DEVICE, MODEL 6198
- Applicant
- Lexion Medical, LLC
- Decision
- Substantially Equivalent
- Date received
- 2006-11-24
- Decision date
- 2007-01-10
- Days to decision
- 47 days
- Clearance type
- Special
- Product code
- HIF
- Device class
- 2
- Regulation number
- 884.1730
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- St. Paul, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.