The following data is part of a premarket notification filed by Allegiance Healthcare Corp. with the FDA for Paracentesis Catheter Device.
| Device ID | K974146 |
| 510k Number | K974146 |
| Device Name: | PARACENTESIS CATHETER DEVICE |
| Classification | Needle, Catheter |
| Applicant | ALLEGIANCE HEALTHCARE CORP. 1435 LAKE COOK RD. Deerfield, IL 60015 |
| Contact | Sharon Robbins |
| Correspondent | Sharon Robbins ALLEGIANCE HEALTHCARE CORP. 1435 LAKE COOK RD. Deerfield, IL 60015 |
| Product Code | GCB |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-03 |
| Decision Date | 1998-01-28 |
| Summary: | summary |