The following data is part of a premarket notification filed by B. Braun Medical Inc. with the FDA for Iv Administration Sets With 200(micro)m Blood Filter.
| Device ID | K143082 |
| 510k Number | K143082 |
| Device Name: | IV Administration Sets With 200(micro)m Blood Filter |
| Classification | Set, Administration, Intravascular |
| Applicant | B. Braun Medical Inc. 901 Marcon Blvd Allentown, PA 18109 |
| Contact | Angela J Caravella |
| Correspondent | Angela J Caravella 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 | 2014-10-27 |
| Decision Date | 2015-07-24 |
| Summary: | summary |