ASAHI AM-R SERIES DIALYZERS— 510(k) K970650

Substantially Equivalent

Asahi Medical Co., Ltd.

FDA 510(k) clearance K970650 for ASAHI AM-R SERIES DIALYZERS, Substantially Equivalent on 1997-09-30. Applicant: Asahi Medical Co., Ltd..

Clearance details

Applicant: Asahi Medical Co., Ltd.
Product code: Code MSE
Advisory panel: Gastroenterology, Urology
Date received: 1997-02-20
Decision date: 1997-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

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