The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for V2 Injection Site.
Device ID | K955585 |
510k Number | K955585 |
Device Name: | V2 INJECTION SITE |
Classification | Set, Administration, Intravascular |
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 | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-12-07 |
Decision Date | 1996-05-15 |
Summary: | summary |