K963574 is an FDA 510(k) clearance for the PULSE*SPRAY INJECTOR. This device is classified as a Pump, Infusion (Class II - Special Controls, product code FRN).
Submitted by AngioDynamics, Inc. (Queensburgy, US). The FDA issued a Cleared decision on July 18, 1997, 315 days after receiving the submission on September 6, 1996.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K963574 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Third Party Review (ST) |
| Date Received | September 06, 1996 |
| Decision Date | July 18, 1997 |
| Days to Decision | 315 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FRN — Pump, Infusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |