FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KOLSTER METHODS
K Number: K935820
·
Decision Jul 19, 1994
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
5
Applicant Total
3
Review Days
228
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Basic Information
- Device Name
- KOLSTER METHODS
- K Number
- K935820
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5070
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Kolster Methods
- Date Received
- December 3, 1993
- Decision Date
- July 19, 1994
- Product Code
- HGH
- 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 |
|---|---|---|---|
| HGH | Cannula, Suction, Uterine | FDA class 2 | Obstetrics/Gynecology |
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