FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENDOSCOPIC FIBEROPTIC CABLE
K Number: K991208
·
Decision Jun 23, 1999
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
27
Applicant Total
3
Review Days
75
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Basic Information
- Device Name
- ENDOSCOPIC FIBEROPTIC CABLE
- K Number
- K991208
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4580
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Isolux America
- Date Received
- April 9, 1999
- Decision Date
- June 23, 1999
- Product Code
- HBI
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| HBI | Illuminator, Fiberoptic, Surgical Field | FDA class 2 | General, Plastic Surgery |
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