The following data is part of a premarket notification filed by Vital Concepts, Inc. with the FDA for Vitaflow Suction/aspiration Tubing Set.
| Device ID | K960616 |
| 510k Number | K960616 |
| Device Name: | VITAFLOW SUCTION/ASPIRATION TUBING SET |
| Classification | Tube, Aspirating, Flexible, Connecting |
| Applicant | VITAL CONCEPTS, INC. 5090 KENDRICK COURT S.E. Grand Rapids, MI 49512 |
| Contact | S. Nicholas Ayoub |
| Correspondent | S. Nicholas Ayoub VITAL CONCEPTS, INC. 5090 KENDRICK COURT S.E. Grand Rapids, MI 49512 |
| Product Code | BYY |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-13 |
| Decision Date | 1996-05-06 |