The following data is part of a premarket notification filed by Concord Laboratories, Inc. with the FDA for Prefilled Pulsator Syringe.
| Device ID | K810995 |
| 510k Number | K810995 |
| Device Name: | PREFILLED PULSATOR SYRINGE |
| Classification | Syringe, Piston |
| Applicant | CONCORD LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-04-13 |
| Decision Date | 1981-05-21 |