Device Classification Name |
mouthguard, over-the-counter
|
510(k) Number |
K094020 |
Device Name |
GRIND NO MORE GENERATION II |
Applicant |
RANIR LLC |
555 THIRTEENTH STREET, NW |
WASHINGTON,
DC
20004
|
|
Applicant Contact |
JONATHAN S KAHAN |
Correspondent |
RANIR LLC |
555 THIRTEENTH STREET, NW |
WASHINGTON,
DC
20004
|
|
Correspondent Contact |
JONATHAN S KAHAN |
Classification Product Code |
|
Date Received | 12/29/2009 |
Decision Date | 01/25/2010 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|