The following data is part of a premarket notification filed by Danville Materials, Inc. with the FDA for Snowpost, Snowlight.
Device ID | K012354 |
510k Number | K012354 |
Device Name: | SNOWPOST, SNOWLIGHT |
Classification | Post, Root Canal |
Applicant | DANVILLE MATERIALS, INC. 2021 OMEGA DR. San Ramon, CA 94583 |
Contact | Craig R Bruns |
Correspondent | Craig R Bruns DANVILLE MATERIALS, INC. 2021 OMEGA DR. San Ramon, CA 94583 |
Product Code | ELR |
CFR Regulation Number | 872.3810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-07-25 |
Decision Date | 2001-10-10 |
Summary: | summary |