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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Washer, Cleaner, Automated, Endoscope
510(k) Number K862402
Device Name OTT DISINFECTOR FOR FLEXIBLE ENDOSCOPES
Applicant
Medivators, Inc.
2550 Multifoods Tower
33 S. Sixth St.
Minneapolis,  MN  55402
Applicant Contact JAMES W MOEN
Correspondent
Medivators, Inc.
2550 Multifoods Tower
33 S. Sixth St.
Minneapolis,  MN  55402
Correspondent Contact JAMES W MOEN
Regulation Number876.1500
Classification Product Code
NVE  
Date Received06/25/1986
Decision Date 02/03/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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