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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name mesh, surgical, polymeric
510(K) Number K070625
Device Name PELVIMESH / HERMESH 7
Applicant
MARKETING SOLUTIONS INC.
8 orange dr.
jericho,  NY  11753
Contact lorena trabucco
Regulation Number878.3300
Classification Product Code
FTL  
Date Received03/06/2007
Decision Date 08/01/2007
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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