FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VOMED URETHRA OLIVE, MODELS 1420 000, 1425 000, 1430 000
K Number: K023019
·
Decision Dec 10, 2002
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
2
Applicant Total
3
Review Days
90
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Basic Information
- Device Name
- VOMED URETHRA OLIVE, MODELS 1420 000, 1425 000, 1430 000
- K Number
- K023019
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Vomed Volzer Medizintechnik GmbH & Co.
- Date Received
- September 11, 2002
- Decision Date
- December 10, 2002
- Product Code
- FGI
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FGI | Catheter, Urethrographic, Male | FDA class 2 | Gastroenterology, Urology |
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