The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for Eva Tpn Container.
Device ID | K041415 |
510k Number | K041415 |
Device Name: | EVA TPN CONTAINER |
Classification | Container, I.v. |
Applicant | B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown, PA 18109 -9341 |
Contact | Amy Smith |
Correspondent | Amy Smith 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 | 2004-05-27 |
Decision Date | 2004-08-04 |
Summary: | summary |