FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OPTIMUM WETTING AND REWETTING DROP
K Number: K001428
·
Decision May 26, 2000
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
32
Applicant Total
4
Review Days
21
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Basic Information
- Device Name
- OPTIMUM WETTING AND REWETTING DROP
- K Number
- K001428
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 886.5918
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lobob Laboratories, Inc.
- Date Received
- May 5, 2000
- Decision Date
- May 26, 2000
- Product Code
- MRC
- 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 |
|---|---|---|---|
| MRC | Products, Contact Lens Care, Rigid Gas Permeable | FDA class 2 | Ophthalmic |
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