The following data is part of a premarket notification filed by Uramix, Inc. with the FDA for Uramix Curaway Biopsy Needle.
Device ID | K203141 |
510k Number | K203141 |
Device Name: | Uramix CuraWay Biopsy Needle |
Classification | Instrument, Biopsy |
Applicant | Uramix, Inc. 272 N. Lansdowne Ave. Lansdowne, PA 19050 |
Contact | Michael Mooreville |
Correspondent | Michael Mooreville Uramix, Inc 272 N. Lansdowne Ave. Lansdowne, PA 19050 |
Product Code | KNW |
CFR Regulation Number | 876.1075 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-10-20 |
Decision Date | 2021-09-17 |