FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ALPHAMEDIX I/A HAND-PIECE, 500-001
K Number: K830812
·
Decision Jun 8, 1983
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
315
Applicant Total
7
Review Days
85
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Basic Information
- Device Name
- ALPHAMEDIX I/A HAND-PIECE, 500-001
- K Number
- K830812
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4670
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Alphamedix, Inc.
- Date Received
- March 15, 1983
- Decision Date
- June 8, 1983
- Product Code
- HQC
- 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 |
|---|---|---|---|
| HQC | Unit, Phacofragmentation | FDA class 2 | Ophthalmic |
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Other Clearances by Alphamedix, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K852706 | VERSABLADE | Nov 4, 1985 | Substantially Equivalent for Some Indications |
| K852633 | VERSABLADE | Nov 4, 1985 | Substantially Equivalent for Some Indications |
| K851272 | VERSAPHAGE | Jul 5, 1985 | Substantially Equivalent |
| K830703 | GLOMARK | Apr 28, 1983 | Substantially Equivalent |
| K820363 | DISPOSABLE SURGICAL GARMENTS | Mar 8, 1982 | Substantially Equivalent |
| K820008 | VERSATOME I | Feb 22, 1982 | Substantially Equivalent |