The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for Blunt Syringe Cannula.
Device ID | K971924 |
510k Number | K971924 |
Device Name: | BLUNT SYRINGE CANNULA |
Classification | Needle, Hypodermic, Single Lumen |
Applicant | B. BRAUN MEDICAL, INC. 824 TWELFTH AVE. Bethlehem, PA 18018 |
Contact | Mark S Alsberge |
Correspondent | Mark S Alsberge B. BRAUN MEDICAL, INC. 824 TWELFTH AVE. Bethlehem, PA 18018 |
Product Code | FMI |
CFR Regulation Number | 880.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-05-23 |
Decision Date | 1998-09-25 |
Summary: | summary |