FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VARICOSCREEN(TM)
K Number: K900404
·
Decision Dec 7, 1990
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
4
Applicant Total
3
Review Days
312
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Basic Information
- Device Name
- VARICOSCREEN(TM)
- K Number
- K900404
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 884.2982
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Promedex, Inc.
- Date Received
- January 29, 1990
- Decision Date
- December 7, 1990
- Product Code
- KYA
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| KYA | System, Thermographic, Liquid Crystal, Nonpowered (Adjunctive Use) | FDA class 1 | Obstetrics/Gynecology |
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