The following data is part of a premarket notification filed by Harbor Medical Devices, Inc. with the FDA for Harborin Central Venous Catheter.
| Device ID | K884628 |
| 510k Number | K884628 |
| Device Name: | HARBORIN CENTRAL VENOUS CATHETER |
| Classification | Cannula, Catheter |
| 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 | DQR |
| CFR Regulation Number | 870.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-07 |
| Decision Date | 1989-05-15 |