FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEXTEC FIBEROPTIC ILLUMINATOR 300 WATT XENON
K Number: K921646
·
Decision May 13, 1992
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
44
Applicant Total
3
Review Days
37
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Basic Information
- Device Name
- NEXTEC FIBEROPTIC ILLUMINATOR 300 WATT XENON
- K Number
- K921646
- 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
- Nextec Corp.
- Date Received
- April 6, 1992
- Decision Date
- May 13, 1992
- Product Code
- FST
- 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 |
|---|---|---|---|
| FST | Light, Surgical, Fiberoptic | FDA class 2 | General, Plastic Surgery |
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