The following data is part of a premarket notification filed by Jayco Pharmaceuticals with the FDA for Abdominal Paracentesis Tray.
| Device ID | K842009 |
| 510k Number | K842009 |
| Device Name: | ABDOMINAL PARACENTESIS TRAY |
| Classification | Tray, Surgical, Instrument |
| Applicant | JAYCO PHARMACEUTICALS 895 POPLAR CHURCH RD. Camp Hill, PA 17011 |
| Contact | Lester J Lifton |
| Correspondent | Lester J Lifton JAYCO PHARMACEUTICALS 895 POPLAR CHURCH RD. Camp Hill, PA 17011 |
| Product Code | FSM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-17 |
| Decision Date | 1984-10-23 |