510(k) K001326
K001326 is an FDA 510(k) premarket notification submitted by Ocular Concepts, LLC for the device "NATURAL-IRIS PRE-PIGMENTED CORNEAL BUTTON". The FDA issued a decision of Substantially Equivalent on June 13, 2000. The device falls under product code NCK (Button, Iris, Eye, Artificial), a Class I device regulated under 21 CFR 886.3200.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 13, 2000
- Date Received
- April 26, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Button, Iris, Eye, Artificial
- Device Class
- Class I
- Regulation Number
- 886.3200
- Review Panel
- OP
- Submission Type