FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AVENT NIPPLE SHIELD
K Number: K944117
·
Decision Oct 5, 1994
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
11
Applicant Total
4
Review Days
43
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Basic Information
- Device Name
- AVENT NIPPLE SHIELD
- K Number
- K944117
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5630
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Avent America, Inc.
- Date Received
- August 23, 1994
- Decision Date
- October 5, 1994
- Product Code
- HFS
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| HFS | Shield, Nipple | FDA class 1 | General Hospital |
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