FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
INSEMINATION CATHETER, MODEL 320301
K Number: K021438
·
Decision Jul 16, 2002
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
28
Applicant Total
3
Review Days
71
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Basic Information
- Device Name
- INSEMINATION CATHETER, MODEL 320301
- K Number
- K021438
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 884.5250
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Labotect Labor-Technik Gottingen
- Date Received
- May 6, 2002
- Decision Date
- July 16, 2002
- Product Code
- MFD
- 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 |
|---|---|---|---|
| MFD | Cannula, Intrauterine Insemination | FDA class 2 | Obstetrics/Gynecology |
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