FDA 510(k)
FDA class 1
Substantially Equivalent
🇪🇸 Spain
BOBES LENS SET
K Number: K945443
·
Decision Jul 19, 1995
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
12
Applicant Total
3
Review Days
254
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Basic Information
- Device Name
- BOBES LENS SET
- K Number
- K945443
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1405
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Bobes S.A.
- Date Received
- November 7, 1994
- Decision Date
- July 19, 1995
- Product Code
- HPC
- 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 |
|---|---|---|---|
| HPC | Set, Lens, Trial, Ophthalmic | FDA class 1 | Ophthalmic |
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