FDA 510(k) Application Details - K842083

Device Classification Name Colonic Irrigation System

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510(K) Number K842083
Device Name Colonic Irrigation System
Applicant COLON THERAPEUTICS
2729 UPTON DR.
PORT ARTHUR, TX US
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Contact JIMMY GIROUARD
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Regulation Number 876.5220

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Classification Product Code KPL
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Date Received 05/23/1984
Decision Date 10/24/1984
Decision SE - Substantially Equivalent
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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