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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name reliner, denture, over the counter
510(k) Number K121318
Device Name PROSOFT
Original Applicant
PERMA LABORATORIES
120 wakefield run blvd
hinckley,  OH  44233
Regulation Number872.3560
Classification Product Code
EBP  
Date Received05/02/2012
Decision Date 06/06/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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