NATURAL-IRIS PRE-PIGMENTED CORNEAL BUTTON
FDA 510(k) clearance K001326 · decided 2000-06-13
Clearance details
- K-number
- K001326
- Device name
- NATURAL-IRIS PRE-PIGMENTED CORNEAL BUTTON
- Applicant
- Ocular Concepts, LLC
- Decision
- Substantially Equivalent
- Date received
- 2000-04-26
- Decision date
- 2000-06-13
- Days to decision
- 48 days
- Clearance type
- Traditional
- Product code
- NCK
- Device class
- 1
- Regulation number
- 886.3200
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Lake Oswego, OR, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.