Device Classification Name |
cleanser, denture, over the counter |
|||
---|---|---|---|---|
510(k) Number | K080631 | |||
Device Name | CLEANSE.FRESHEN.GO; ALIGNER CLEANSING TOWELETTE AND DENTAL APPLIANCE CLEANSER | |||
Applicant |
|
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Applicant Contact | robert e tricca | |||
Correspondent |
|
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Correspodent Contact | robert e tricca | |||
Regulation Number | 872.3520 | |||
Classification Product Code |
|
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Date Received | 03/05/2008 | |||
Decision Date | 05/23/2008 | |||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
Dental |
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510k Review Panel |
Dental |
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summary |
summary |
|||
Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |