The following data is part of a premarket notification filed by Hdc Corp. with the FDA for Ibis Chemo-port Implantable Vascular Access System, Model 700-08-10,700-08-11,700-08-12,700-08-15,700-08-16,735-08-10.
| Device ID | K002770 |
| 510k Number | K002770 |
| Device Name: | IBIS CHEMO-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM, MODEL 700-08-10,700-08-11,700-08-12,700-08-15,700-08-16,735-08-10 |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | HDC CORP. 2109 O'TOOLE AVE. San Jose, CA 95131 |
| Contact | Earl Smart |
| Correspondent | Earl Smart HDC CORP. 2109 O'TOOLE AVE. San Jose, CA 95131 |
| Product Code | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-06 |
| Decision Date | 2000-09-26 |