FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MENICON SP VIAL
K Number: K950878
·
Decision Apr 7, 1995
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
79
Applicant Total
4
Review Days
38
Basic Information
- Device Name
- MENICON SP VIAL
- K Number
- K950878
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.5928
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Hyman, Phelps & McNamara, P.C.
- Date Received
- February 28, 1995
- Decision Date
- April 7, 1995
- Product Code
- LRX
- 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 |
|---|---|---|---|
| LRX | Case, Contact Lens | FDA class 2 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LRX), ordered by most recent decision date.
CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6)
FDA 510(k)
FDA Class 2
·Ophthalmic
Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Case - classic flat pack (CL-02); Phoenix Contact Lens Case - sunglass shape flat pack (CL-03)
FDA 510(k)
FDA Class 2
·Ophthalmic
Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc
FDA 510(k)
FDA Class 2
·Ophthalmic
Contact Lens Case, Model: A-1, B-1
FDA 510(k)
FDA Class 2
·Ophthalmic
Bausch + Lomb Boston Scleral Lens Case
FDA 510(k)
FDA Class 2
·Ophthalmic
Contact Lens Case
FDA 510(k)
FDA Class 2
·Ophthalmic