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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 K080095
Device Name CORAMATE/SPIROTOME SYSTEM
Applicant
Medinvents
Klein Hillststraat 5
Hasselt, Limburg,  BE 3500
Applicant Contact JAAK JANSSENS
Correspondent
Medinvents
Klein Hillststraat 5
Hasselt, Limburg,  BE 3500
Correspondent Contact JAAK JANSSENS
Regulation Number876.1075
Classification Product Code
KNW  
Date Received01/14/2008
Decision Date 04/11/2008
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
Recalls CDRH Recalls
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