FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CANNON BABYSAFE NIPPLE SHIELDS
K Number: K853176
·
Decision Aug 22, 1985
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
11
Applicant Total
19
Review Days
41
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Basic Information
- Device Name
- CANNON BABYSAFE NIPPLE SHIELDS
- K Number
- K853176
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5630
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Medela, Inc.
- Date Received
- July 12, 1985
- Decision Date
- August 22, 1985
- 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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