The following data is part of a premarket notification filed by U-needle B.v. with the FDA for Bella-mu.
Device ID | K190962 |
510k Number | K190962 |
Device Name: | Bella-mu |
Classification | Needle, Hypodermic, Single Lumen |
Applicant | U-Needle B.V. De Veldmaat 10 Enschede, NL 7522 Nm |
Contact | Gert Veldhuis |
Correspondent | Robert Packard Medical Device Academy, Inc. 345 Lincoln Hill Road Shrewsbury, VT 05738 |
Product Code | FMI |
CFR Regulation Number | 880.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-04-12 |
Decision Date | 2020-02-03 |