The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Ionoseal.
Device ID | K912495 |
510k Number | K912495 |
Device Name: | IONOSEAL |
Classification | Liner, Cavity, Calcium Hydroxide |
Applicant | VOCO GMBH C/ONDA RESOURCES 790 WASHINGTON STREET, STE 301 Denver, CO 80203 |
Contact | Gail E Gillenwater |
Correspondent | Gail E Gillenwater VOCO GMBH C/ONDA RESOURCES 790 WASHINGTON STREET, STE 301 Denver, CO 80203 |
Product Code | EJK |
CFR Regulation Number | 872.3250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-06-05 |
Decision Date | 1991-07-30 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
IONOSEAL 79228758 not registered Dead/Abandoned |
VOCO GmbH 2018-01-11 |