FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SCLERAL PLUG
K Number: K831193
·
Decision Jun 30, 1983
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
9
Applicant Total
22
Review Days
79
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Basic Information
- Device Name
- SCLERAL PLUG
- K Number
- K831193
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4155
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Medical Instrument Development Laboratories, Inc.
- Date Received
- April 12, 1983
- Decision Date
- June 30, 1983
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LXP), ordered by most recent decision date.
SCLERAL PLUGS, 19 AND 20 GAUGE
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ADVANCED SURGICAL 19 & 20 GAUGE DISP. SCLERAL PLUG
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PRISMA DISPOSABLE 19 AND 20 GAUGE SCLERAL PLUGS
FDA 510(k)
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·Ophthalmic
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| K932669 | SUPRA-VIT(TM) | Jun 3, 1994 | Substantially Equivalent |
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| K851610 | COMBINED MVS SYSTEMS | Jul 22, 1985 | Substantially Equivalent |