FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Aqua Naina Sterile Saline Solution
K Number: K193441
·
Decision May 26, 2020
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
119
Applicant Total
2
Review Days
167
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Basic Information
- Device Name
- Aqua Naina Sterile Saline Solution
- K Number
- K193441
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.5928
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Chemtex USA, Inc.
- Date Received
- December 11, 2019
- Decision Date
- May 26, 2020
- Product Code
- LPN
- 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 |
|---|---|---|---|
| LPN | Accessories, Soft Lens Products | FDA class 2 | Ophthalmic |
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Other Clearances by Chemtex USA, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K221263 | Aqua Naina Plus Sterile Saline Solution | Oct 12, 2022 | Substantially Equivalent |