The following data is part of a premarket notification filed by Wilson-cook Medical, Inc with the FDA for Wilson-cook Mini Basket.
Device ID | K182381 |
510k Number | K182381 |
Device Name: | Wilson-Cook Mini Basket |
Classification | Dislodger, Stone, Biliary |
Applicant | Wilson-Cook Medical, Inc 4900 Bethania Station Road Winston-salem, NC 27105 |
Contact | Tiffanny A. Thomas |
Correspondent | Tiffanny A. Thomas Wilson-Cook Medical, Inc 4900 Bethania Station Road Winston-salem, NC 27105 |
Product Code | LQR |
CFR Regulation Number | 876.5010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-08-31 |
Decision Date | 2018-10-30 |
Summary: | summary |