FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LEADING EDGE OPHTHALMIC KNIFE
K Number: K831975
·
Decision Aug 31, 1983
Classifications
1
FEI Numbers
206
Registration Numbers
207
Same Product Code
53
Applicant Total
4
Review Days
72
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Basic Information
- Device Name
- LEADING EDGE OPHTHALMIC KNIFE
- K Number
- K831975
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4350
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Surgidev Corp.
- Date Received
- June 20, 1983
- Decision Date
- August 31, 1983
- Product Code
- HNN
- 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 |
|---|---|---|---|
| HNN | Knife, Ophthalmic | FDA class 1 | Ophthalmic |
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