The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for Dual Spike Transfer Device.
| Device ID | K120150 |
| 510k Number | K120150 |
| Device Name: | DUAL SPIKE TRANSFER DEVICE |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown, PA 18109 -9341 |
| Contact | Bonnie Kincaid |
| Correspondent | Bonnie Kincaid B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown, PA 18109 -9341 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-18 |
| Decision Date | 2012-05-24 |
| Summary: | summary |