The following data is part of a premarket notification filed by Nikkiso Co. Ltd. with the FDA for Nikkline Blood Tubing Lines With Transducer Protectors, Models Av06a-p, Avo6b-p, Av06c-p.
| Device ID | K082719 |
| 510k Number | K082719 |
| Device Name: | NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS, MODELS AV06A-P, AVO6B-P, AV06C-P |
| Classification | Accessories, Blood Circuit, Hemodialysis |
| Applicant | NIKKISO CO. LTD. 4-2-1 YUSHIMA BUNKYO-KU Tokyo, JP 113-0034 |
| Contact | Fumiaki Kanai |
| Correspondent | Fumiaki Kanai NIKKISO CO. LTD. 4-2-1 YUSHIMA BUNKYO-KU Tokyo, JP 113-0034 |
| Product Code | KOC |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-17 |
| Decision Date | 2009-03-30 |
| Summary: | summary |