FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SAPPHIRE KNIFE BLADE
K Number: K861744
·
Decision Jun 9, 1986
Classifications
1
FEI Numbers
207
Registration Numbers
208
Same Product Code
53
Applicant Total
59
Review Days
34
Basic Information
- Device Name
- SAPPHIRE KNIFE BLADE
- K Number
- K861744
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4350
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- KEELER INSTRUMENTS, INC.
- Date Received
- May 6, 1986
- Decision Date
- June 9, 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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| K973064 | KEELER TEARSCOPE-PLUS | Apr 7, 1998 | Substantially Equivalent |
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