The following data is part of a premarket notification filed by Bioject, Inc. with the FDA for Reconstitution Kit & Vial Connector.
| Device ID | K010623 |
| 510k Number | K010623 |
| Device Name: | RECONSTITUTION KIT & VIAL CONNECTOR |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | BIOJECT, INC. 7620 S.W. BRIDGEPORT RD. Portland, OR 97224 |
| Contact | Nancy Gertlar |
| Correspondent | Nancy Gertlar 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 | 2001-03-02 |
| Decision Date | 2001-04-05 |