The following data is part of a premarket notification filed by Sooil Development Co., Ltd. with the FDA for Dana Diabecare Iis.
| Device ID | K063126 |
| 510k Number | K063126 |
| Device Name: | DANA DIABECARE IIS |
| Classification | Pump, Infusion, Insulin |
| Applicant | SOOIL DEVELOPMENT CO., LTD. 5677 OBERLIN DRIVE, SUITE 101 San Diego, CA 92121 |
| Contact | Jeremy Kim |
| Correspondent | Jeremy Kim SOOIL DEVELOPMENT CO., LTD. 5677 OBERLIN DRIVE, SUITE 101 San Diego, CA 92121 |
| Product Code | LZG |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-13 |
| Decision Date | 2007-02-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809220584862 | K063126 | 000 |
| 08809220584855 | K063126 | 000 |