FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THE FUGO BLADE
K Number: K001498
·
Decision Aug 10, 2000
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
2
Applicant Total
4
Review Days
87
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Basic Information
- Device Name
- THE FUGO BLADE
- K Number
- K001498
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4100
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medisurg , Ltd.
- Date Received
- May 15, 2000
- Decision Date
- August 10, 2000
- Product Code
- NCR
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| NCR | Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered | FDA class 2 | Ophthalmic |
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