The following data is part of a premarket notification filed by Neostar Medical Technologies, Inc. with the FDA for Dual Lumen Catheter (dlc) Tray.
| Device ID | K941851 |
| 510k Number | K941851 |
| Device Name: | DUAL LUMEN CATHETER (DLC) TRAY |
| Classification | Accessories, Blood Circuit, Hemodialysis |
| Applicant | NEOSTAR MEDICAL TECHNOLOGIES, INC. 201 NORTH CENTER DR. North Brunswick, NJ 08902 |
| Contact | Balbir Kapany |
| Correspondent | Balbir Kapany NEOSTAR MEDICAL TECHNOLOGIES, INC. 201 NORTH CENTER DR. North Brunswick, NJ 08902 |
| Product Code | KOC |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-14 |
| Decision Date | 1995-03-13 |