The following data is part of a premarket notification filed by Terumo Corp. with the FDA for Terumo Venoject,luer Adapter.
| Device ID | K983490 |
| 510k Number | K983490 |
| Device Name: | TERUMO VENOJECT,LUER ADAPTER |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | TERUMO CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Contact | Kristine Wagner |
| Correspondent | Kristine Wagner TERUMO CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-05 |
| Decision Date | 1998-11-30 |
| Summary: | summary |