The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Venoject Ii Blood Collection Tubes.
| Device ID | K900309 |
| 510k Number | K900309 |
| Device Name: | VENOJECT II BLOOD COLLECTION TUBES |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Contact | George S Momoda |
| Correspondent | George S Momoda TERUMO MEDICAL 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 | 1990-01-22 |
| Decision Date | 1990-03-15 |