FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICROVISION SCLERAL BUCKLING COMPONENTS
K Number: K023481
·
Decision Jan 8, 2003
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
15
Applicant Total
3
Review Days
83
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Basic Information
- Device Name
- MICROVISION SCLERAL BUCKLING COMPONENTS
- K Number
- K023481
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.3340
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Microvision, Inc.
- Date Received
- October 17, 2002
- Decision Date
- January 8, 2003
- Product Code
- HQX
- 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 |
|---|---|---|---|
| HQX | Implant, Orbital, Extra-Ocular | FDA class 2 | Ophthalmic |
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