The following data is part of a premarket notification filed by Argon Medical Corp. with the FDA for Closed System Flush Set.
| Device ID | K904994 |
| 510k Number | K904994 |
| Device Name: | CLOSED SYSTEM FLUSH SET |
| Classification | Injector And Syringe, Angiographic |
| Applicant | ARGON MEDICAL CORP. 1445 FLAT CREEK RD. P.O. BOX 1970 Athens, TX 75751 |
| Contact | Gail Doherty |
| Correspondent | Gail Doherty ARGON MEDICAL CORP. 1445 FLAT CREEK RD. P.O. BOX 1970 Athens, TX 75751 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-07 |
| Decision Date | 1991-01-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20886333208795 | K904994 | 000 |
| 20886333208771 | K904994 | 000 |
| 20886333208757 | K904994 | 000 |
| 20886333208740 | K904994 | 000 |
| 20886333208726 | K904994 | 000 |
| 20886333208696 | K904994 | 000 |
| 20886333207644 | K904994 | 000 |