The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Continu-flo Solution W/check Valve 2 Y-inject Site.
| Device ID | K873894 |
| 510k Number | K873894 |
| Device Name: | CONTINU-FLO SOLUTION W/CHECK VALVE 2 Y-INJECT SITE |
| Classification | Set, Administration, Intravascular |
| Applicant | TRAVENOL LABORATORIES, S.A. WILSON RD. AT ROUTE 120 P.O. BOX 490 Round Lake, IL 60073 |
| Contact | Dennis Ocwieja |
| Correspondent | Dennis Ocwieja TRAVENOL LABORATORIES, S.A. WILSON RD. AT ROUTE 120 P.O. BOX 490 Round Lake, IL 60073 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-24 |
| Decision Date | 1987-11-05 |