LANSINOH POWERED ELECTRIC BREAST PUMP
FDA 510(k) clearance K122474 · decided 2012-12-28
Clearance details
- K-number
- K122474
- Device name
- LANSINOH POWERED ELECTRIC BREAST PUMP
- Applicant
- Lansinoh Laboratories Saglik Gerecleri Tasarim San
- Decision
- Substantially Equivalent
- Date received
- 2012-08-14
- Decision date
- 2012-12-28
- Days to decision
- 136 days
- Clearance type
- Special
- Product code
- HGX
- Device class
- 2
- Regulation number
- 884.5160
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Westminster, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.