The following data is part of a premarket notification filed by Tri-med, Inc. with the FDA for Paracentesis Trays.
| Device ID | K961863 |
| 510k Number | K961863 |
| Device Name: | PARACENTESIS TRAYS |
| Classification | General Surgery Tray |
| Applicant | TRI-MED, INC. 16309 WEST 108TH CIRCLE Lenexa, KS 66219 |
| Contact | Mike Knoth |
| Correspondent | Mike Knoth TRI-MED, INC. 16309 WEST 108TH CIRCLE Lenexa, KS 66219 |
| Product Code | LRO |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-14 |
| Decision Date | 1996-05-28 |