The following data is part of a premarket notification filed by Sooil Development Co., Ltd. with the FDA for Dana Diabecare Ii Insulin Pump & Superline-easyrelease, Soft-release-st, & Soft-release-r Infusion Sets.
| Device ID | K022317 |
| 510k Number | K022317 |
| Device Name: | DANA DIABECARE II INSULIN PUMP & SUPERLINE-EASYRELEASE, SOFT-RELEASE-ST, & SOFT-RELEASE-R INFUSION SETS |
| Classification | Pump, Infusion, Insulin |
| Applicant | SOOIL DEVELOPMENT CO., LTD. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Cynthia J.m. Nolte |
| Correspondent | Cynthia J.m. Nolte SOOIL DEVELOPMENT CO., LTD. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | LZG |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-17 |
| Decision Date | 2002-08-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809220580048 | K022317 | 000 |
| 08809220580031 | K022317 | 000 |
| 08809220580017 | K022317 | 000 |
| 18809220580434 | K022317 | 000 |