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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name staple, implantable
510(k) Number K110728
Device Name IMESH TACKER
Applicant
EASYLAP LTD.
24301 woodsage drive
bonita springs,  FL  34134
Applicant Contact paul dryden
Correspondent
EASYLAP LTD.
24301 woodsage drive
bonita springs,  FL  34134
Correspondent Contact paul dryden
Regulation Number878.4750
Classification Product Code
GDW  
Date Received03/16/2011
Decision Date 06/08/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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