The following data is part of a premarket notification filed by B. Braun Medical Inc. with the FDA for Iv Administration Sets.
Device ID | K170595 |
510k Number | K170595 |
Device Name: | IV Administration Sets |
Classification | Set, Administration, Intravascular |
Applicant | B. Braun Medical Inc. 901 Macon Blvd Allentown, PA 18109 |
Contact | Nancy Skocypec |
Correspondent | Nancy Skocypec B. Braun Medical Inc. 901 Macon 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 | 2017-02-28 |
Decision Date | 2017-11-07 |
Summary: | summary |