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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Marker, Colon
510(k) Number K042901
Device Name ENDOMARK STERILE INDIA INK
Applicant
Pmt Corp.
1500 Park Rd.
Chanhassen,  MN  55317
Applicant Contact JAMES R VEALE
Correspondent
Medical Device Consultants, Inc.
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact JAMES R VEALE
Regulation Number876.1500
Classification Product Code
NBG  
Date Received10/20/2004
Decision Date 03/16/2005
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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