The following data is part of a premarket notification filed by Oxyless Ltd with the FDA for Oxyless Blood Tubing Set.
| Device ID | K150304 |
| 510k Number | K150304 |
| Device Name: | Oxyless Blood Tubing Set |
| Classification | Set, Tubing, Blood, With And Without Anti-regurgitation Valve |
| Applicant | Oxyless Ltd Third Floor, Bewlay House, 2 Swallow Place London, GB |
| Contact | Bob Duffy |
| Correspondent | Bob Duffy Bob Duffy Associates 16405 Summer Sage Road Poway, CA 92064 |
| Product Code | FJK |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-06 |
| Decision Date | 2016-02-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15060493650009 | K150304 | 000 |