FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BAERVELDT GLAUCOMA IMPLANT
K Number: K905129
·
Decision Feb 11, 1991
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
24
Applicant Total
3
Review Days
89
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Basic Information
- Device Name
- BAERVELDT GLAUCOMA IMPLANT
- K Number
- K905129
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.3920
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Wright Medical Corp.
- Date Received
- November 14, 1990
- Decision Date
- February 11, 1991
- Product Code
- KYF
- 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 |
|---|---|---|---|
| KYF | Implant, Eye Valve | FDA class 2 | Ophthalmic |
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