The following data is part of a premarket notification filed by Halkey-roberts Corp. with the FDA for Robertsite Stopcock.
| Device ID | K061143 |
| 510k Number | K061143 |
| Device Name: | ROBERTSITE STOPCOCK |
| Classification | Stopcock, I.v. Set |
| Applicant | HALKEY-ROBERTS CORP. 11600 M.L. KING BLVD.,NORTH St. Petersburg, FL 33716 |
| Contact | Radames Pierantoni |
| Correspondent | Jeffrey D Rongero UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | FMG |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-04-25 |
| Decision Date | 2006-05-10 |
| Summary: | summary |