FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VERSAPHAGE
K Number: K851272
·
Decision Jul 5, 1985
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
148
Applicant Total
7
Review Days
95
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Basic Information
- Device Name
- VERSAPHAGE
- K Number
- K851272
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4150
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Alphamedix, Inc.
- Date Received
- April 1, 1985
- Decision Date
- July 5, 1985
- Product Code
- HQE
- 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 |
|---|---|---|---|
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 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 |
| K830812 | ALPHAMEDIX I/A HAND-PIECE, 500-001 | Jun 8, 1983 | 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 |