FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SWIFT LOW PROFILE CUP (PRO CUP)
K Number: K013460
·
Decision Jan 17, 2002
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
28
Applicant Total
3
Review Days
91
Basic Information
- Device Name
- SWIFT LOW PROFILE CUP (PRO CUP)
- K Number
- K013460
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4340
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- SWIFT DELIVERY PRODUCTS
- Date Received
- October 18, 2001
- Decision Date
- January 17, 2002
- Product Code
- HDB
- 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 |
|---|---|---|---|
| HDB | Extractor, Vacuum, Fetal | FDA class 2 | Obstetrics/Gynecology |
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