FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VACULINK, MODEL VCL 3000
K Number: K043614
·
Decision Apr 14, 2005
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
28
Applicant Total
1
Review Days
105
Basic Information
- Device Name
- VACULINK, MODEL VCL 3000
- K Number
- K043614
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4340
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MEDEVCO, INC.
- Date Received
- December 30, 2004
- Decision Date
- April 14, 2005
- 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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