FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
TOMMEE TIPPEE CLOSER TO NATURE ELECTRIC BREAST PUMP
K Number: K110343
·
Decision Mar 11, 2011
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
202
Applicant Total
1
Review Days
35
Basic Information
- Device Name
- TOMMEE TIPPEE CLOSER TO NATURE ELECTRIC BREAST PUMP
- K Number
- K110343
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5160
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MAYBORN BABY AND CHILD / JACKEL INTERNATIONAL LTD
- Date Received
- February 4, 2011
- Decision Date
- March 11, 2011
- Product Code
- HGX
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HGX | Pump, Breast, Powered | FDA class 2 | Obstetrics/Gynecology |
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