The following data is part of a premarket notification filed by Vital Concepts, Inc. with the FDA for Vci Suction/irrigation Tubing Set.
| Device ID | K934382 |
| 510k Number | K934382 |
| Device Name: | VCI SUCTION/IRRIGATION TUBING SET |
| Classification | Catheter And Tip, Suction |
| Applicant | VITAL CONCEPTS, INC. 4315 AIRWEST DR. S.E. Grand Rapids, MI 49512 |
| Contact | S. Nicholas Ayoub |
| Correspondent | S. Nicholas Ayoub VITAL CONCEPTS, INC. 4315 AIRWEST DR. S.E. Grand Rapids, MI 49512 |
| Product Code | JOL |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-09 |
| Decision Date | 1994-02-01 |