FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MITYVAC MERLIN, MODEL 10027
K Number: K020447
·
Decision Apr 12, 2002
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
28
Applicant Total
4
Review Days
60
Basic Information
- Device Name
- MITYVAC MERLIN, MODEL 10027
- K Number
- K020447
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 884.4340
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- PRISM ENTERPRISES, INC.
- Date Received
- February 11, 2002
- Decision Date
- April 12, 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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