The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for Sterican Hypodermic Needles.
Device ID | K072247 |
510k Number | K072247 |
Device Name: | STERICAN HYPODERMIC NEEDLES |
Classification | Needle, Hypodermic, Single Lumen |
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 | FMI |
CFR Regulation Number | 880.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-08-13 |
Decision Date | 2007-11-08 |
Summary: | summary |