The following data is part of a premarket notification filed by Cardiac Pacemakers, Inc. with the FDA for 9110 Syringe.
| Device ID | K822774 |
| 510k Number | K822774 |
| Device Name: | 9110 SYRINGE |
| Classification | Syringe, Piston |
| Applicant | CARDIAC PACEMAKERS, INC. MN |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-09-14 |
| Decision Date | 1982-11-03 |