The following data is part of a premarket notification filed by Cascades Device Consulting Associates with the FDA for Hydrocolor 5.
| Device ID | K102739 |
| 510k Number | K102739 |
| Device Name: | HYDROCOLOR 5 |
| Classification | Material, Impression |
| Applicant | CASCADES DEVICE CONSULTING ASSOCIATES 19379 BLUE LAKE LOOP Bend, OR 97702 -1923 |
| Contact | Gerald W Shipps |
| Correspondent | Gerald W Shipps CASCADES DEVICE CONSULTING ASSOCIATES 19379 BLUE LAKE LOOP Bend, OR 97702 -1923 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-22 |
| Decision Date | 2010-12-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00883205107633 | K102739 | 000 |
| 00883205107626 | K102739 | 000 |