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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cutter, Surgical
510(k) Number K112400
Device Name SMARTSHEARS
Applicant
Nuscience Consulting and Management Group, LLC
P.O. Box 8507
Fleming Island,  FL  32006
Applicant Contact NIKOLE GOLDSMITH
Correspondent
Nuscience Consulting and Management Group, LLC
P.O. Box 8507
Fleming Island,  FL  32006
Correspondent Contact NIKOLE GOLDSMITH
Regulation Number878.4800
Classification Product Code
FZT  
Date Received08/19/2011
Decision Date 09/12/2011
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
Predetermined Change
Control Plan Authorized		 No
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