The following data is part of a premarket notification filed by Toray Industries (america), Inc. with the FDA for Filtryzer.
Device ID | K940910 |
510k Number | K940910 |
Device Name: | FILTRYZER |
Classification | Dialyzer, Capillary, Hollow Fiber |
Applicant | TORAY INDUSTRIES (AMERICA), INC. 600 THIRD AVE. New York, NY 10016 |
Contact | Lisa S Jones |
Correspondent | Lisa S Jones TORAY INDUSTRIES (AMERICA), INC. 600 THIRD AVE. New York, NY 10016 |
Product Code | FJI |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-02-25 |
Decision Date | 1995-05-04 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
FILTRYZER 73427316 1283245 Live/Registered |
Toray Kabushiki Kaisha 1983-05-24 |