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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Biopsy
510(k) Number K150088
Device Name Evacore Fully Disposable Vacuum Assist Biopsy Device
Applicant
Pin-Point Care Corp.
N1723 Center St.
Lebanon,  WI  53047
Applicant Contact Jeff M Hathaway
Correspondent
Pin-Point Care Corp.
N1723 Center St.
Lebanon,  WI  53047
Correspondent Contact Jeff M Hathaway
Regulation Number876.1075
Classification Product Code
KNW  
Date Received01/16/2015
Decision Date 07/20/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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