HEMOSORBA CH-500, CH-350 AND CH-180— 510(k) K885017
Substantially EquivalentAsahi Medical Co., Ltd.
FDA 510(k) clearance K885017 for HEMOSORBA CH-500, CH-350 AND CH-180, Substantially Equivalent on 1989-03-17. Applicant: Asahi Medical Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Asahi Medical Co., Ltd.
- Product code
- Code FLD
- Device class
- Class 2
- Regulation
- 21 CFR 876.5870
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Washington, DC, US
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