The following data is part of a premarket notification filed by Hdc Corp. with the FDA for Hdc Chemo-port (vascular).
Device ID | K853332 |
510k Number | K853332 |
Device Name: | HDC CHEMO-PORT (VASCULAR) |
Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
Applicant | HDC CORP. 2551 CASEY AVE. Mountain View, CA 94043 |
Contact | William J Schroder |
Correspondent | William J Schroder HDC CORP. 2551 CASEY AVE. Mountain View, CA 94043 |
Product Code | LJT |
CFR Regulation Number | 880.5965 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-08-08 |
Decision Date | 1986-07-17 |