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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 K862058
Device Name RAPID ENDOSCOPIC LAVAGE SYSTEM
Applicant
Endovations
895 Poplar Church Rd.
Camp Hill,  PA  17011
Applicant Contact KAREN S BUTT
Correspondent
Endovations
895 Poplar Church Rd.
Camp Hill,  PA  17011
Correspondent Contact KAREN S BUTT
Regulation Number876.1500
Classification Product Code
OCX  
Date Received05/30/1986
Decision Date 08/11/1986
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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