FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MITYVAC
K Number: K011532
·
Decision Jul 30, 2001
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
28
Applicant Total
4
Review Days
73
Basic Information
- Device Name
- MITYVAC
- K Number
- K011532
- 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
- May 18, 2001
- Decision Date
- July 30, 2001
- 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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