The following data is part of a premarket notification filed by Harbor Medical Devices, Inc. with the FDA for Single Lumen S.e.a.-port Vascular Access System.
| Device ID | K890518 |
| 510k Number | K890518 |
| Device Name: | SINGLE LUMEN S.E.A.-PORT VASCULAR ACCESS SYSTEM |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | HARBOR MEDICAL DEVICES, INC. 25 DRYDOCK AVE. Boston, MA 02210 -3912 |
| Contact | Joshua Tolkoff |
| Correspondent | Joshua Tolkoff HARBOR MEDICAL DEVICES, INC. 25 DRYDOCK AVE. Boston, MA 02210 -3912 |
| Product Code | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-02 |
| Decision Date | 1989-04-21 |