The following data is part of a premarket notification filed by Halkey-roberts Corp. with the FDA for Robertsite Vial Adapter, Model 245700021.
| Device ID | K040634 |
| 510k Number | K040634 |
| Device Name: | ROBERTSITE VIAL ADAPTER, MODEL 245700021 |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | HALKEY-ROBERTS CORP. 11600 M.L. KING BLVD.,NORTH St. Petersburg, FL 33716 |
| Contact | John Sheldon |
| Correspondent | Susan Gill UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-03-10 |
| Decision Date | 2004-03-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20634624031603 | K040634 | 000 |