FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NIPLETTE
K Number: K952035
·
Decision Jul 28, 1995
Classifications
1
FEI Numbers
91
Registration Numbers
91
Same Product Code
26
Applicant Total
4
Review Days
88
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Basic Information
- Device Name
- NIPLETTE
- K Number
- K952035
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 884.5150
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Avent America, Inc.
- Date Received
- May 1, 1995
- Decision Date
- July 28, 1995
- Product Code
- HGY
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HGY | Pump, Breast, Non-Powered | FDA class 1 | Obstetrics/Gynecology |
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