The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for 20 Mmvial Fluid Transfer Adapter, Model 7e2500.
| Device ID | K100640 |
| 510k Number | K100640 |
| Device Name: | 20 MMVIAL FLUID TRANSFER ADAPTER, MODEL 7E2500 |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown, PA 18109 -9341 |
| Contact | Matthew Homa |
| Correspondent | Matthew Homa 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 | 2010-03-05 |
| Decision Date | 2010-07-22 |
| Summary: | summary |