FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DESIGNS FOR VISION FIBEROPTIC LIGHT
K Number: K032283
·
Decision Aug 20, 2003
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
6
Applicant Total
5
Review Days
27
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Basic Information
- Device Name
- DESIGNS FOR VISION FIBEROPTIC LIGHT
- K Number
- K032283
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Designs For Vision, Inc.
- Date Received
- July 24, 2003
- Decision Date
- August 20, 2003
- Product Code
- GDB
- 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 |
|---|---|---|---|
| GDB | Endoscope, Fiber Optic | FDA class 2 | Gastroenterology, Urology |
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