HEMOCLEAN— 510(k) K023064
Substantially EquivalentKrd Co., Ltd.
FDA 510(k) clearance K023064 for HEMOCLEAN, Substantially Equivalent on 2004-04-06. Applicant: Krd Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Krd Co., Ltd.
- Product code
- Code NII
- Device class
- Class 2
- Regulation
- 21 CFR 876.5860
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Edina, MN, US
Recent devices under product code NII
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