The following data is part of a premarket notification filed by B. Braun Of America, Inc. with the FDA for Charged Supor(r) Filter Extension Set.
| Device ID | K940980 |
| 510k Number | K940980 |
| Device Name: | CHARGED SUPOR(R) FILTER EXTENSION SET |
| Classification | Filter, Infusion Line |
| Applicant | B. BRAUN OF AMERICA, INC. 824 TWELFTH AVE. Bethlehem, PA 18018 |
| Contact | Thomas R Ronca |
| Correspondent | Thomas R Ronca B. BRAUN OF AMERICA, INC. 824 TWELFTH AVE. Bethlehem, PA 18018 |
| Product Code | FPB |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-01 |
| Decision Date | 1994-07-14 |