The following data is part of a premarket notification filed by Hdc Corp. with the FDA for Chemo-port Non-coring Needles.
Device ID | K873165 |
510k Number | K873165 |
Device Name: | CHEMO-PORT NON-CORING NEEDLES |
Classification | Needle, Hypodermic, Single Lumen |
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 | FMI |
CFR Regulation Number | 880.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-08-11 |
Decision Date | 1987-12-03 |