510(k) K023064
- Device
- HEMOCLEAN
- Applicant
- KRD CO., LTD
- 510(k) number
- K023064
- Product code
- NII
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-04-06
- Date received
- 2002-09-16
- Regulation
- 876.5860
- Classification name
- Disinfectant, Dialysate Delivery System
- Medical specialty
- Gastroenterology/Urology
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JEFFERY R SHIDEMAN
- Address
- Anderson Consulting Intl. 7307 Glouchester Dr. Edina MN US 55435 55435
FDA Registration Numbers#
- 3005162618
- 9611823
- 3035708507
- 3004111573
- 8030665
- 3005578748
- 3016096143
- 1225714
- 3019131
- 3043014136
- 9611824
- 3015335038
Source Documents#
Other 510(k) Records For Product Code NII #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K043207 | OZONE GENERATOR | Ge Infrastructure Water & Process Technologies | 2005-11-04 |
Legacy Summary#
summary
FDA Review#
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