DANA DIABECARE
Pump, Infusion, Insulin
SOOIL DEVELOPMENT CO., LTD.
The following data is part of a premarket notification filed by Sooil Development Co., Ltd. with the FDA for Dana Diabecare.
Pre-market Notification Details
| Device ID | K001604 |
| 510k Number | K001604 |
| Device Name: | DANA DIABECARE |
| Classification | Pump, Infusion, Insulin |
| Applicant | SOOIL DEVELOPMENT CO., LTD. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Cynthia J Nolte |
| Correspondent | Cynthia J 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-24 |
| Decision Date | 2000-08-14 |
Trademark Results [DANA DIABECARE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DANA DIABECARE 75541919 2396338 Live/Registered |
Sooil Development Co., Ltd. 1998-08-24 |
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