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 |