The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Clirans Te08 Hollow Fiber Dialyzer.
Device ID | K823768 |
510k Number | K823768 |
Device Name: | CLIRANS TE08 HOLLOW FIBER DIALYZER |
Classification | Unit, Cryophthalmic, Ac-powered |
Applicant | TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
Product Code | HRN |
CFR Regulation Number | 886.4170 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-12-14 |
Decision Date | 1983-01-08 |