The following data is part of a premarket notification filed by George Taub Products & Fusion Co., Inc. with the FDA for Hydroxyline.
Device ID | K833640 |
510k Number | K833640 |
Device Name: | HYDROXYLINE |
Classification | Liner, Cavity, Calcium Hydroxide |
Applicant | GEORGE TAUB PRODUCTS & FUSION CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EJK |
CFR Regulation Number | 872.3250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-10-17 |
Decision Date | 1984-02-27 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
HYDROXYLINE 76469822 2766653 Live/Registered |
George Taub Products and Fusion Company, Inc. 2002-11-25 |
HYDROXYLINE 73807029 1611832 Dead/Cancelled |
GEORGE TAUB PRODUCTS AND FUSION CO., INC. 1989-06-16 |