The following data is part of a premarket notification filed by B.braun Medical Inc. with the FDA for Iv Administration Set.
Device ID | K173361 |
510k Number | K173361 |
Device Name: | IV Administration Set |
Classification | Set, Administration, Intravascular |
Applicant | B.Braun Medical Inc. 901 Marcon Blvd Allentown, PA 18109 |
Contact | Nancy Skocypec |
Correspondent | Nancy Skocypec B.Braun Medical Inc. 901 Marcon Blvd Allentown, PA 18109 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-10-26 |
Decision Date | 2018-06-26 |
Summary: | summary |