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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 K914145
Device Name DSD-91(TM) DISINFECTOR FOR FLEXIBLE ENDOSCOPES
Applicant
MEDIVATORS, INC.
c/o c. g. bundy associates
6470 riverview terrace
minneapolis,  MN  55432
Contact constance g bundy
Regulation Number876.1500
Classification Product Code
FEB  
Date Received09/16/1991
Decision Date 02/22/1994
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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