Device Classification Name |
Mouthguard, Over-The-Counter
|
510(k) Number |
K082301 |
Device Name |
GRIND NO MORE |
Applicant |
PLACONTROL INC. |
555 THIRTEENTH STREET NW |
WASHINGTON,
DC
20004
|
|
Applicant Contact |
JONATHAN S KAHAN |
Correspondent |
PLACONTROL INC. |
555 THIRTEENTH STREET NW |
WASHINGTON,
DC
20004
|
|
Correspondent Contact |
JONATHAN S KAHAN |
Classification Product Code |
|
Date Received | 08/12/2008 |
Decision Date | 10/06/2008 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|