The following data is part of a premarket notification filed by Cardiac Pacemakers, Inc. with the FDA for Reservoir 1.5cc #9210 W/25 Gauge/needle.
| Device ID | K831259 |
| 510k Number | K831259 |
| Device Name: | RESERVOIR 1.5CC #9210 W/25 GAUGE/NEEDLE |
| Classification | Pump, Infusion |
| Applicant | CARDIAC PACEMAKERS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-18 |
| Decision Date | 1983-05-09 |