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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 K020614
Device Name IRRIGATING CANNULA
Applicant
Ca Guard, Ltd.
19526 E. Lake Dr.
Miami,  FL  33015
Applicant Contact AL WEISENBORN
Correspondent
Ca Guard, Ltd.
19526 E. Lake Dr.
Miami,  FL  33015
Correspondent Contact AL WEISENBORN
Regulation Number876.1500
Classification Product Code
OCX  
Subsequent Product Code
GCJ  
Date Received02/25/2002
Decision Date 05/24/2002
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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