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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Cleaning, For Endoscope
510(k) Number K961607
Device Name VIRAPUMP II (MODELS AND MODEL M)
Applicant
Viatro, Corp.
6779 Engle Rd.
Cleveland,  OH  44130
Applicant Contact JAN J LEWANDOWSKI
Correspondent
Viatro, Corp.
6779 Engle Rd.
Cleveland,  OH  44130
Correspondent Contact JAN J LEWANDOWSKI
Regulation Number876.1500
Classification Product Code
FEB  
Date Received04/25/1996
Decision Date 12/06/1996
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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