Device Classification Name |
mouthguard, prescription |
||||
---|---|---|---|---|---|
510(k) Number | K111066 | ||||
Device Name | MIGRA TAB, QUICKSPLINT MIGRAINE | ||||
Applicant |
|
||||
Applicant Contact | bradley eli | ||||
Correspondent |
|
||||
Correspodent Contact | bradley eli | ||||
Classification Product Code |
|
||||
Date Received | 04/18/2011 | ||||
Decision Date | 11/22/2011 | ||||
Decision |
substantially equivalent (SESE) |
||||
510k Review Panel |
Dental |
||||
summary |
summary |
||||
Type | Traditional | ||||
Reviewed by Third Party | No | ||||
Combination Product |
No |