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 |