510(k) K001326
- Device
- NATURAL-IRIS PRE-PIGMENTED CORNEAL BUTTON
- Applicant
- OCULAR CONCEPTS LLC.
- 510(k) number
- K001326
- Product code
- NCK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-06-13
- Date received
- 2000-04-26
- Regulation
- 886.3200
- Classification name
- Button, Iris, Eye, Artificial
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KEVIN SCHOU
- Address
- 4035 SW Mercantile Dr. Suite #208 Lake Oswego OR US 97035 97035
FDA Registration Numbers#
- 3042953262
- 3004475955
- 3042228518
Source Documents#
Legacy Summary#
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FDA Review#
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