FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SCLERAL PLUGS, 19 AND 20 GAUGE
K Number: K022186
·
Decision Feb 26, 2003
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
9
Applicant Total
3
Review Days
236
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Basic Information
- Device Name
- SCLERAL PLUGS, 19 AND 20 GAUGE
- K Number
- K022186
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4155
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Microvision, Inc.
- Date Received
- July 5, 2002
- Decision Date
- February 26, 2003
- Product Code
- LXP
- 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 |
|---|---|---|---|
| LXP | Plug, Scleral | FDA class 2 | Ophthalmic |
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