Aqua Naina Plus Sterile Saline Solution
FDA 510(k) clearance K221263 · decided 2022-10-12
Clearance details
- K-number
- K221263
- Device name
- Aqua Naina Plus Sterile Saline Solution
- Applicant
- Chemtex USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-05-02
- Decision date
- 2022-10-12
- Days to decision
- 163 days
- Clearance type
- Special
- Product code
- LPN
- Device class
- 2
- Regulation number
- 886.5928
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Fairfield, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.