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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCARISOLV MINIMAL INVASIVE DENTAL CARIES REMOVAL SYSTEM
Generic Namesolution, removal, carries
ApplicantRLS GLOBAL AB
neongatan 5
molndal S-431-431-
PMA NumberP000005
Supplement NumberS005
Date Received07/09/2002
Decision Date10/23/2002
Product Code LMW 
Advisory Committee Dental
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A MODIFICATION TO THE FORMULATION OF CARISOLV.
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