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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Irrigation/Suction System
510(k) Number K833331
Device Name ASPIRATION & IRRIGATION CATHETER
Applicant
MICROVASIVE
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
MICROVASIVE
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number876.1500
Classification Product Code
OCX  
Date Received09/27/1983
Decision Date 11/14/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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