EYE-CEPT STERILE SALINE SOLUTION
FDA 510(k) clearance K110221 · decided 2011-11-01
Clearance details
- K-number
- K110221
- Device name
- EYE-CEPT STERILE SALINE SOLUTION
- Applicant
- Optics Laboratory, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-01-25
- Decision date
- 2011-11-01
- Days to decision
- 280 days
- Clearance type
- Traditional
- Product code
- LPN
- Device class
- 2
- Regulation number
- 886.5928
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- El Monte, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.