MIPUMP SINGLE ELECTRIC/BATTERY BREAT PUMP & MIPUMP DOUBLE ELECTRIC/BATTERY BREAST PUMP & MIPUMP DELUXE DOUBLE ELECTRIC/B
FDA 510(k) clearance K082802 · decided 2008-10-09
Clearance details
- K-number
- K082802
- Device name
- MIPUMP SINGLE ELECTRIC/BATTERY BREAT PUMP & MIPUMP DOUBLE ELECTRIC/BATTERY BREAST PUMP & MIPUMP DELUXE DOUBLE ELECTRIC/B
- Applicant
- Learning Curve Brands Inc. the First Years
- Decision
- Substantially Equivalent
- Date received
- 2008-09-24
- Decision date
- 2008-10-09
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- HGX
- Device class
- 2
- Regulation number
- 884.5160
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Stoughton, MA, US
- Third-party review
- Yes
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.