The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Calcicur.
Device ID | K926419 |
510k Number | K926419 |
Device Name: | CALCICUR |
Classification | Liner, Cavity, Calcium Hydroxide |
Applicant | VOCO GMBH C/O MEDICAL DEVICE RESOURCES 7527 WESTMORELAND AVENUE St. Louis, MO 63105 |
Contact | Evan G Dick |
Correspondent | Evan G Dick VOCO GMBH C/O MEDICAL DEVICE RESOURCES 7527 WESTMORELAND AVENUE St. Louis, MO 63105 |
Product Code | EJK |
CFR Regulation Number | 872.3250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-12-23 |
Decision Date | 1993-03-31 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CALCICUR 79097635 4040451 Live/Registered |
VOCO GmbH 2011-02-08 |