The following data is part of a premarket notification filed by Whip Mix Corporation with the FDA for Vericore Gradient Temporary Disc.
Device ID | K152443 |
510k Number | K152443 |
Device Name: | Vericore Gradient Temporary Disc |
Classification | Crown And Bridge, Temporary, Resin |
Applicant | WHIP MIX CORPORATION 361 FARMINGTON AVENUE Louisville, KY 40217 |
Contact | John Waters |
Correspondent | John Waters WHIP MIX CORPORATION 361 FARMINGTON AVENUE Louisville, KY 40217 |
Product Code | EBG |
CFR Regulation Number | 872.3770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-08-27 |
Decision Date | 2016-05-11 |
Summary: | summary |