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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration
510(k) Number K860599
Device Name ETHOX LAVAGE TUBE
Applicant
Ethox Corp.
251 Seneca St.
Buffalo,  NY  14204
Applicant Contact FRANK P WILTON
Correspondent
Ethox Corp.
251 Seneca St.
Buffalo,  NY  14204
Correspondent Contact FRANK P WILTON
Regulation Number876.5980
Classification Product Code
KDH  
Date Received02/19/1986
Decision Date 03/11/1986
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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