510(k) Premarket Notification Database
Device Classification Name |
powder, porcelain
|
510(k) Number | K981490 |
Device Name | WILLI GELLER CREATION PORCELAIN |
Applicant |
JENSEN INDUSTRIES, INC.
|
50 stillman rd. |
north haven,
CT
06473 |
|
Contact | john slanski |
Regulation Number | 872.6660 |
Classification Product Code |
|
Date Received | 04/27/1998 |
Decision Date | 10/22/1998 |
Decision |
substantially equivalent (SE) |
Classification Advisory Committee |
Dental
|
Review Advisory Committee |
Dental
|
Statement/Summary/Purged Status |
Summary only
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Expedited Review |
No
|
|
|