The following data is part of a premarket notification filed by Hdc Corp. with the FDA for Chemo-port.
| Device ID | K913386 |
| 510k Number | K913386 |
| Device Name: | CHEMO-PORT |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | HDC CORP. 2109 O'TOOLE AVE. San Jose, CA 95131 |
| Contact | Gretchen Marchesani |
| Correspondent | Gretchen Marchesani HDC CORP. 2109 O'TOOLE AVE. San Jose, CA 95131 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-29 |
| Decision Date | 1992-01-10 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CHEMO-PORT 76187123 2563443 Dead/Cancelled |
HDC Corporation 2000-12-27 |
![]() CHEMO-PORT 73560657 1424709 Dead/Cancelled |
HDC CORPORATION 1985-09-30 |