FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
CLERZ LUBRICATING/REWETTING SOLUTION
K Number: K833494
·
Decision Jan 4, 1984
Classifications
1
FEI Numbers
36
Registration Numbers
37
Same Product Code
57
Applicant Total
97
Review Days
89
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Basic Information
- Device Name
- CLERZ LUBRICATING/REWETTING SOLUTION
- K Number
- K833494
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1930
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- CooperVision, Inc.
- Date Received
- October 7, 1983
- Decision Date
- January 4, 1984
- Product Code
- HKX
- 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 |
|---|---|---|---|
| HKX | Tonometer, Ac-Powered | FDA class 2 | Ophthalmic |
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