The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for B. Braun 0.2 Micron Filter.
Device ID | K052773 |
510k Number | K052773 |
Device Name: | B. BRAUN 0.2 MICRON FILTER |
Classification | Syringe, Piston |
Applicant | B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown, PA 18109 -9341 |
Contact | Christine Ford |
Correspondent | Christine Ford B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown, PA 18109 -9341 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-10-03 |
Decision Date | 2006-01-24 |
Summary: | summary |