HEMOCLEAN
Disinfectant, Dialysate Delivery System
KRD CO., LTD
The following data is part of a premarket notification filed by Krd Co., Ltd with the FDA for Hemoclean.
Pre-market Notification Details
| Device ID | K023064 |
| 510k Number | K023064 |
| Device Name: | HEMOCLEAN |
| Classification | Disinfectant, Dialysate Delivery System |
| Applicant | KRD CO., LTD ANDERSON CONSULTING INTL. 7307 GLOUCHESTER DRIVE Edina, MN 55435 |
| Contact | Jeffery R Shideman |
| Correspondent | Jeffery R Shideman KRD CO., LTD ANDERSON CONSULTING INTL. 7307 GLOUCHESTER DRIVE Edina, MN 55435 |
| Product Code | NII |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-16 |
| Decision Date | 2004-04-06 |
| Summary: | summary |
Trademark Results [HEMOCLEAN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HEMOCLEAN 77719597 not registered Dead/Abandoned |
KRD CO., LTD. 2009-04-22 |
 HEMOCLEAN 76606716 not registered Dead/Abandoned |
Lee, Jin-Tae 2004-08-12 |
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