The following data is part of a premarket notification filed by Argon Medical Corp. with the FDA for Central Catheter Kit.
Device ID | K780673 |
510k Number | K780673 |
Device Name: | CENTRAL CATHETER KIT |
Classification | Tubing, Fluid Delivery |
Applicant | ARGON MEDICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FPK |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-04-24 |
Decision Date | 1978-05-16 |