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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 K822061
Device Name LAVAGING CATHETERS
Applicant
American Endoscopy, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
American Endoscopy, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number876.1500
Classification Product Code
OCX  
Date Received07/13/1982
Decision Date 07/20/1982
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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