The following data is part of a premarket notification filed by Medisystems Corp. with the FDA for Arterial Venous Blood Tubing Set.
| Device ID | K953823 |
| 510k Number | K953823 |
| Device Name: | ARTERIAL VENOUS BLOOD TUBING SET |
| Classification | Set, Tubing, Blood, With And Without Anti-regurgitation Valve |
| Applicant | MEDISYSTEMS CORP. 1575 EYE ST., N.W. Washington, DC 20005 |
| Contact | Suzan Onel |
| Correspondent | Suzan Onel MEDISYSTEMS CORP. 1575 EYE ST., N.W. Washington, DC 20005 |
| Product Code | FJK |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-15 |
| Decision Date | 1996-09-23 |
| Summary: | summary |