The following data is part of a premarket notification filed by Tri-med Specialties, Inc. with the FDA for Paracentesis Needles/cannulas.
| Device ID | K945160 |
| 510k Number | K945160 |
| Device Name: | PARACENTESIS NEEDLES/CANNULAS |
| Classification | General Surgery Tray |
| Applicant | TRI-MED SPECIALTIES, INC. P.O. BOX 23306 Overland Park, KS 66223 |
| Contact | Mike Knoth |
| Correspondent | Mike Knoth TRI-MED SPECIALTIES, INC. P.O. BOX 23306 Overland Park, KS 66223 |
| Product Code | LRO |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-21 |
| Decision Date | 1994-11-14 |