Breast Pump Kit
The Breast Pump Kit is a convenience kit containing the components of a breast pump system, used by breastfeeding mothers to express milk for later feeding. Classified as FDA Class 2 under regulation 21 CFR 884.5160 within the Obstetrics/Gynecology medical specialty, it falls under enforcement discretion per the FDA's May 1997 Convenience Kits Interim Regulatory Guidance and does not require a 510(k) when all applicable criteria are satisfied. The product code is OHH. It is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- OHH
- Device Class
- FDA class 2
- Regulation Number
- 884.5160
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 7
Device Characteristics
Definition
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
FEI Numbers
This FDA classification entry is associated with 32 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 32 registration numbers. Click on an entry to view related FDA registrations.