The following data is part of a premarket notification filed by B. Braun Medical Inc. with the FDA for Iv Administration Sets.
| Device ID | K202618 |
| 510k Number | K202618 |
| Device Name: | IV Administration Sets |
| Classification | Set, Administration, Intravascular |
| Applicant | B. Braun Medical Inc. 901 Marcon Blvd. Allentown, PA 18109 -9341 |
| Contact | Kimberly Smith |
| Correspondent | Kimberly Smith B. Braun Medical Inc. 901 Marcon Blvd. Allentown, PA 18109 -9341 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-10 |
| Decision Date | 2021-09-24 |