The following data is part of a premarket notification filed by Neostar Medical Technologies, Inc. with the FDA for Acute Central Venous Access Catheter Tray.
| Device ID | K944660 |
| 510k Number | K944660 |
| Device Name: | ACUTE CENTRAL VENOUS ACCESS CATHETER TRAY |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | NEOSTAR MEDICAL TECHNOLOGIES, INC. 100 ROSS RD. King Of Prussia, PA 19406 |
| Contact | Troy M Harmon |
| Correspondent | Troy M Harmon NEOSTAR MEDICAL TECHNOLOGIES, INC. 100 ROSS RD. King Of Prussia, PA 19406 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-21 |
| Decision Date | 1995-03-13 |