FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DIAMOND BLADE MICROMETER KNIFE
K Number: K860332
·
Decision Feb 13, 1986
Classifications
1
FEI Numbers
206
Registration Numbers
207
Same Product Code
53
Applicant Total
5
Review Days
15
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Basic Information
- Device Name
- DIAMOND BLADE MICROMETER KNIFE
- K Number
- K860332
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4350
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Med-Tech Develoment Corp.
- Date Received
- January 29, 1986
- Decision Date
- February 13, 1986
- 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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Other Clearances by Med-Tech Develoment Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K860852 | SAPPHIRE BLADE SURGICAL KNIFE | Mar 28, 1986 | Substantially Equivalent |
| K860329 | FYODOROV RADIAL KERATOTOMY MARKER SET | Feb 12, 1986 | Substantially Equivalent |
| K860331 | DISPOSABLE SURGICAL KNIFE | Feb 12, 1986 | Substantially Equivalent |
| K860330 | MAKLAKOV STYLE TONOMETER | Feb 12, 1986 | Substantially Equivalent |