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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 K052100
Device Name MODIFICATION TO MOTIFMESH SOFT TISSUE PATCH
Applicant
PROXY BIOMEDICAL LTD.
P.O. BOX 560
STILLWATER,  MN  55082
Applicant Contact ELAINE DUNCAN
Correspondent
PROXY BIOMEDICAL LTD.
P.O. BOX 560
STILLWATER,  MN  55082
Correspondent Contact ELAINE DUNCAN
Regulation Number878.3300
Classification Product Code
FTL  
Date Received08/03/2005
Decision Date 08/11/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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