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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biopsy Needle
510(k) Number K062979
Device Name THYROSAMPLER
Applicant
Acd Medical Innovation Corp.
13 Red Fox Ln.
Littleton,  CO  80127
Applicant Contact Kevin Walls
Correspondent
Acd Medical Innovation Corp.
13 Red Fox Ln.
Littleton,  CO  80127
Correspondent Contact Kevin Walls
Regulation Number876.1075
Classification Product Code
FCG  
Date Received09/29/2006
Decision Date 05/30/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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