510(k) K072643
- Device
- CRYSTALEYE SPECTROPHOTOMETER/CRYSTALEYE BASIC SET, MODEL CE100-DC/US
- Applicant
- Olympus Corporation
- 510(k) number
- K072643
- Product code
- KZN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-11-16
- Date received
- 2007-09-18
- Regulation
- 872.3661
- Classification name
- Scanner, Color
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- FUMIAKI KANAI
- Address
- 4-2-1 Yushima Bunkyo-Ku Tokyo JP 113-0034 113-0034
FDA Registration Numbers#
- 3015914458
- 3015915424
- 3009482106
- 3015790896
- 3043496869
Source Documents#
Other 510(k) Records For Product Code KZN#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K770667 | CHROMASCAN TM | Sterndent Corp. | 1977-04-20 |