510(k) Premarket Notification Database
Device Classification Name |
alloy, gold-based noble metal
|
510(k) Number | K922774 |
Device Name | COLLEGIATE |
Applicant |
J.F. JELENKO & CO., INC.
|
99 business park dr. |
armonk,
NY
10504 |
|
Contact | costantino volpe |
Regulation Number | 872.3060 |
Classification Product Code |
|
Date Received | 06/09/1992 |
Decision Date | 12/04/1992 |
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 |
|
|
|