The following data is part of a premarket notification filed by Harbor Medical Devices, Inc. with the FDA for Harbor S.e.a.-port Surgical Accessory Kit.
| Device ID | K882657 |
| 510k Number | K882657 |
| Device Name: | HARBOR S.E.A.-PORT SURGICAL ACCESSORY KIT |
| Classification | Introducer, 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 | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-29 |
| Decision Date | 1988-12-13 |