The following data is part of a premarket notification filed by Allegiance Healthcare Corp. with the FDA for Flexible Vascular Clamp, Version 2.
| Device ID | K991589 |
| 510k Number | K991589 |
| Device Name: | FLEXIBLE VASCULAR CLAMP, VERSION 2 |
| Classification | Clamp, Vascular |
| Applicant | ALLEGIANCE HEALTHCARE CORP. 1500 WAUKEGAN RD.- K Mcgraw Park, IL 60085 |
| Contact | Patricia Sharpe-gregg |
| Correspondent | Patricia Sharpe-gregg ALLEGIANCE HEALTHCARE CORP. 1500 WAUKEGAN RD.- K Mcgraw Park, IL 60085 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-07 |
| Decision Date | 1999-05-18 |
| Summary: | summary |