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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 K142477
Device Name Intact Advance and Intact Excision XL, Intact BLES
Applicant
INTACT MEDICAL CORPORATION
550 COCHITUATE RD
SUITE 25
FRAMINGHAM,  MA  01701
Applicant Contact JOHN VACHA
Correspondent
HOGAN LOVELLS US LLP
555 THIRTEENTH STREET. NW
WASHINGTON,  DC  20004
Correspondent Contact JOHN J SMITH
Regulation Number876.1075
Classification Product Code
KNW  
Date Received09/03/2014
Decision Date 12/15/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Clinical Trials NCT00720642
Reviewed by Third Party No
Combination Product No
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