MEDELA ELECTRIC BREAST PUMP
FDA 510(k) clearance K801862 · decided 1980-10-23
Clearance details
- K-number
- K801862
- Device name
- MEDELA ELECTRIC BREAST PUMP
- Applicant
- Medela, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-08-05
- Decision date
- 1980-10-23
- Days to decision
- 79 days
- Clearance type
- Traditional
- Product code
- HGX
- Device class
- 2
- Regulation number
- 884.5160
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Sterile single/double breast personal accessory convenience kit for single or double pumpi recall (Z-2485-2010) | Medela Inc | 2010-09-24 |