The following data is part of a premarket notification filed by Medical Dynamics, Inc. with the FDA for Adair/veress Needle Introducer Set.
| Device ID | K900374 |
| 510k Number | K900374 |
| Device Name: | ADAIR/VERESS NEEDLE INTRODUCER SET |
| Classification | Needle, Catheter |
| Applicant | MEDICAL DYNAMICS, INC. 99 INVERNESS DR., EAST Englewood, CO 80112 |
| Contact | Jo Brehm |
| Correspondent | Jo Brehm MEDICAL DYNAMICS, INC. 99 INVERNESS DR., EAST Englewood, CO 80112 |
| Product Code | GCB |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-26 |
| Decision Date | 1990-04-20 |