FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRA
K Number: K832074
·
Decision Aug 1, 1983
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
15
Applicant Total
97
Review Days
34
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Basic Information
- Device Name
- CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRA
- K Number
- K832074
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4150
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- CooperVision, Inc.
- Date Received
- June 28, 1983
- Decision Date
- August 1, 1983
- Product Code
- HKP
- 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 |
|---|---|---|---|
| HKP | Instrument, Vitreous Aspiration And Cutting, Battery-Powered | FDA class 2 | Ophthalmic |
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