The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for Pulse*spray Injector.
| Device ID | K963574 |
| 510k Number | K963574 |
| Device Name: | PULSE*SPRAY INJECTOR |
| Classification | Pump, Infusion |
| Applicant | ANGIODYNAMICS, INC. 603 QUEENSBURY AVE. Queensbury, NY 12804 |
| Contact | Jeffrey R Mannion |
| Correspondent | Jeffrey R Mannion ANGIODYNAMICS, INC. 603 QUEENSBURY AVE. Queensbury, NY 12804 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-06 |
| Decision Date | 1997-07-18 |