(46 days)
The White River Mini Manual Breast Pump is used to sustain lactation, milk collection, relief of breast engorgement, and for relief of sore or cracked nipples.
Not Found
I am sorry, but this document contains no information about acceptance criteria or a study that proves a device meets acceptance criteria. It is a letter from the FDA regarding a 510(k) premarket notification for a "Mini Manual Breast Pump" and an "Indications for Use" statement for the same device.
§ 884.5150 Nonpowered breast pump.
(a)
Identification. A nonpowered breast pump is a manual suction device used to express milk from the breast.(b)
Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9, if the device is using either a bulb or telescoping mechanism which does not develop more than 250 mm Hg suction, and the device materials that contact breast or breast milk do not produce cytotoxicity, irritation, or sensitization effects.