The following data is part of a premarket notification filed by Vital Concepts, Inc. with the FDA for Vci Insuflator Filter W/ Tubing.
| Device ID | K930192 |
| 510k Number | K930192 |
| Device Name: | VCI INSUFLATOR FILTER W/ TUBING |
| Classification | Insufflator, Laparoscopic |
| Applicant | VITAL CONCEPTS, INC. 4315 AIRWEST DR. S.E. Grand Rapids, MI 49512 |
| Contact | Nicholas Ayoub |
| Correspondent | Nicholas Ayoub VITAL CONCEPTS, INC. 4315 AIRWEST DR. S.E. Grand Rapids, MI 49512 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-14 |
| Decision Date | 1994-03-02 |