The following data is part of a premarket notification filed by Argon Medical Corp. with the FDA for Hydroglide Spring Guide Wires.
Device ID | K841926 |
510k Number | K841926 |
Device Name: | HYDROGLIDE SPRING GUIDE WIRES |
Classification | Wire, Guide, Catheter |
Applicant | ARGON MEDICAL CORP. P.O. BOX 1970 Athens, TX 75751 |
Contact | Van Hine |
Correspondent | Van Hine ARGON MEDICAL CORP. P.O. BOX 1970 Athens, TX 75751 |
Product Code | DQX |
CFR Regulation Number | 870.1330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-05-10 |
Decision Date | 1985-01-02 |