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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 K081057
Device Name INTACT BREAST LESION EXCISION SYSTEM WITH INTACT EXCISION XL
Applicant
INTACT MEDICAL CORPORATION
ONE APPLE HILL SUITE 316
NATICK,  MA  01760
Applicant Contact DOUGLAS MACARTHUR
Correspondent
INTACT MEDICAL CORPORATION
ONE APPLE HILL SUITE 316
NATICK,  MA  01760
Correspondent Contact DOUGLAS MACARTHUR
Regulation Number876.1075
Classification Product Code
KNW  
Date Received04/14/2008
Decision Date 06/17/2008
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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