The following data is part of a premarket notification filed by Hdc Corp. with the FDA for Chemo-cath Intraperitoneal Catheter.
Device ID | K863819 |
510k Number | K863819 |
Device Name: | CHEMO-CATH INTRAPERITONEAL CATHETER |
Classification | Catheter, Peritoneal, Long-term Indwelling |
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 | FJS |
CFR Regulation Number | 876.5630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-09-30 |
Decision Date | 1987-02-04 |