The following data is part of a premarket notification filed by Diag Corp. with the FDA for Seal-away Hemostasis Adapter, Model 406229.
| Device ID | K984062 |
| 510k Number | K984062 |
| Device Name: | SEAL-AWAY HEMOSTASIS ADAPTER, MODEL 406229 |
| Classification | Introducer, Catheter |
| Applicant | DIAG CORP. 14901 DEVEAU PLACE Minnetonka, MN 55345 -2126 |
| Contact | Todd Kornmann |
| Correspondent | Todd Kornmann DIAG CORP. 14901 DEVEAU PLACE Minnetonka, MN 55345 -2126 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-16 |
| Decision Date | 1999-03-24 |
| Summary: | summary |