The following data is part of a premarket notification filed by B. Braun Of America, Inc. with the FDA for Trumpet Valve.
Device ID | K911415 |
510k Number | K911415 |
Device Name: | TRUMPET VALVE |
Classification | Stopcock, I.v. Set |
Applicant | B. BRAUN OF AMERICA, INC. 824 TWELFTH AVE. PO BOX 4027 Bethlehem, PA 18018 -0027 |
Contact | Peggy Keiffer |
Correspondent | Peggy Keiffer B. BRAUN OF AMERICA, INC. 824 TWELFTH AVE. PO BOX 4027 Bethlehem, PA 18018 -0027 |
Product Code | FMG |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-04-01 |
Decision Date | 1991-06-03 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
TRUMPET VALVE 72375740 0917965 Live/Registered |
FLOW CONDITIONING CORP. 1970-11-12 |