The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for Dual Chamber Tpn Container.
| Device ID | K073538 |
| 510k Number | K073538 |
| Device Name: | DUAL CHAMBER TPN CONTAINER |
| Classification | Container, I.v. |
| Applicant | B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown, PA 18109 -9341 |
| Contact | Tracy Maddock |
| Correspondent | Tracy Maddock B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown, PA 18109 -9341 |
| Product Code | KPE |
| CFR Regulation Number | 880.5025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-17 |
| Decision Date | 2008-03-12 |
| Summary: | summary |