510(k) Premarket Notification Database
Device Classification Name |
alloy, gold-based noble metal
|
510(k) Number | K915612 |
Device Name | ARGENCO Y + |
Applicant |
ARGEN PRECIOUS METALS, INC.
|
8380 miralani dr. |
san diego,
CA
92126 |
|
Contact | lal malhotra |
Regulation Number | 872.3060 |
Classification Product Code |
|
Date Received | 12/16/1991 |
Decision Date | 01/07/1994 |
Decision |
substantially equivalent (SE) |
Classification Advisory Committee |
Dental
|
Review Advisory Committee |
Dental
|
Statement/Summary/Purged Status |
Statement only
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Expedited Review |
|
|
|