The following data is part of a premarket notification filed by Sooil Development Co., Ltd. with the FDA for Dana 3cc Syringe Insulin Reservoir.
| Device ID | K071418 |
| 510k Number | K071418 |
| Device Name: | DANA 3CC SYRINGE INSULIN RESERVOIR |
| Classification | Accessories, Pump, Infusion |
| Applicant | SOOIL DEVELOPMENT CO., LTD. 49 PLAIN STREET North Attleboro, MA 02760 |
| Contact | Cynthia Nolte, Ph.d |
| Correspondent | Cynthia Nolte, Ph.d SOOIL DEVELOPMENT CO., LTD. 49 PLAIN STREET North Attleboro, MA 02760 |
| Product Code | MRZ |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-22 |
| Decision Date | 2007-09-04 |
| Summary: | summary |