The following data is part of a premarket notification filed by B. Braun Medical Inc. with the FDA for Extension Set.
| Device ID | K153293 |
| 510k Number | K153293 |
| Device Name: | Extension Set |
| 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 | 2015-11-13 |
| Decision Date | 2016-04-06 |
| Summary: | summary |