The following data is part of a premarket notification filed by Endovations with the FDA for Cleaning Brush.
Device ID | K874239 |
510k Number | K874239 |
Device Name: | CLEANING BRUSH |
Classification | Accessories, Cleaning Brushes, For Endoscope |
Applicant | ENDOVATIONS 895 POPLAR CHURCH RD. Camp Hill, PA 17011 |
Contact | Susan P Bjorkman |
Correspondent | Susan P Bjorkman ENDOVATIONS 895 POPLAR CHURCH RD. Camp Hill, PA 17011 |
Product Code | MNL |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-10-16 |
Decision Date | 1987-12-29 |