Cleared Traditional

ASAHI AM-BIO SERIES DIALYZERS (WET MODELS)& (DRY MODELS), MODELS AM-BIO-50,AM-BIO-65, AM-BIO-75, AND AM-BIO-100, AM-BIO-

K983720 · Asahi Medical Co., Ltd. · Gastroenterology & Urology
May 1999
Decision
208d
Days
Class 2
Risk

About This 510(k) Submission

K983720 is an FDA 510(k) clearance for the ASAHI AM-BIO SERIES DIALYZERS (WET MODELS)& (DRY MODELS), MODELS AM-BIO-50,AM-BIO-65, AM-BIO-75, AND AM-BIO-100, AM-BIO-, a Hemodialyzer, Re-use, Low Flux (Class II — Special Controls, product code MSE), submitted by Asahi Medical Co., Ltd. (Rockville, US). The FDA issued a Cleared decision on May 17, 1999, 208 days after receiving the submission on October 21, 1998. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.

Submission Details

510(k) Number K983720 FDA.gov
FDA Decision Cleared SESE
Date Received October 21, 1998
Decision Date May 17, 1999
Days to Decision 208 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code MSE — Hemodialyzer, Re-use, Low Flux
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5820

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