The following data is part of a premarket notification filed by Asahi Medical Co., Ltd. with the FDA for New Am-series Dialyzers.
Device ID | K892374 |
510k Number | K892374 |
Device Name: | NEW AM-SERIES DIALYZERS |
Classification | Dialyzer, Capillary, Hollow Fiber |
Applicant | ASAHI MEDICAL CO., LTD. INTL. SQUARE 1825 EYE ST., N.W., SUITE 400 Washington, DC 20006 |
Contact | Richard T Ney |
Correspondent | Richard T Ney ASAHI MEDICAL CO., LTD. INTL. SQUARE 1825 EYE ST., N.W., SUITE 400 Washington, DC 20006 |
Product Code | FJI |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-03-31 |
Decision Date | 1989-05-18 |