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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 K152596
Device Name Intact® Gen2 System
Applicant
Intact Medical Corporation
550 Cochituate Rd. Suite 25
Framingham,  MA  01701
Applicant Contact JOHN VACHA
Correspondent
Hogan Lovells US LLP
555 Thirteenth St. NW
Washington,  DC  22204
Correspondent Contact JOHN J SMITH
Regulation Number876.1075
Classification Product Code
KNW  
Date Received09/10/2015
Decision Date 02/15/2016
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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