The following data is part of a premarket notification filed by Bioject, Inc. with the FDA for Bioject Needle-free Vial Adapter (13mm).
| Device ID | K963012 |
| 510k Number | K963012 |
| Device Name: | BIOJECT NEEDLE-FREE VIAL ADAPTER (13MM) |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | BIOJECT, INC. 7620 S.W. BRIDGEPORT RD. Portland, OR 97224 |
| Contact | Jeff Snow |
| Correspondent | Jeff Snow BIOJECT, INC. 7620 S.W. BRIDGEPORT RD. Portland, OR 97224 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-02 |
| Decision Date | 1996-10-15 |
| Summary: | summary |