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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 K002479
Device Name BIOMESH P1 AND BIOMESH PLUG AND PATCH
Applicant
COUSIN BIOTECH S.A.R.L
555 thirteenth street, n.w.
washington,  DC  20004 1109
Contact howard m holstein
Regulation Number878.3300
Classification Product Code
FTL  
Date Received08/11/2000
Decision Date 10/19/2000
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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