| Device Classification Name |
saliva, artificial |
||||
|---|---|---|---|---|---|
| 510(k) Number | K111250 | ||||
| Device Name | DRY MOUTH MOUTHWASH | ||||
| Applicant |
|
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| Applicant Contact | camille thornton | ||||
| Correspondent |
|
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| Correspodent Contact | camille thornton | ||||
| Classification Product Code |
|
||||
| Date Received | 05/04/2011 | ||||
| Decision Date | 04/27/2012 | ||||
| Decision |
substantially equivalent (SESE) |
||||
| 510k Review Panel |
Dental |
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| summary |
summary |
||||
| Type | Traditional | ||||
| Reviewed by Third Party | No | ||||
| Combination Product |
No |