FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RK VACUUM FIXATION RING SYSTEM
K Number: K863775
·
Decision Oct 20, 1986
Classifications
1
FEI Numbers
90
Registration Numbers
90
Same Product Code
6
Applicant Total
17
Review Days
24
Basic Information
- Device Name
- RK VACUUM FIXATION RING SYSTEM
- K Number
- K863775
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4350
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- AMERITEK, INC.
- Date Received
- September 26, 1986
- Decision Date
- October 20, 1986
- Product Code
- HNH
- 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 |
|---|---|---|---|
| HNH | Ring, Ophthalmic (Flieringa) | FDA class 1 | Ophthalmic |
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