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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 K090271
Device Name HYDROCOAT MESH
Original Applicant
PROMETHEAN SURGICAL DEVICES, INC.
111 roberts st., suite g2
east hartford,  CT  06108
Original Contact kenneth k kleinhenz
Regulation Number878.3300
Classification Product Code
FTL  
Date Received02/04/2009
Decision Date 01/14/2010
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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