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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
FOIA Releasable 510(k) K914145
Device Name DSD-91(TM) DISINFECTOR FOR FLEXIBLE ENDOSCOPES
Applicant
Medivators, Inc.
C/O C.G. Bundy Associates
6470 Riverview Ter.
Minneapolis,  MN  55432
Applicant Contact CONSTANCE G BUNDY
Correspondent
Medivators, Inc.
C/O C.G. Bundy Associates
6470 Riverview Ter.
Minneapolis,  MN  55432
Correspondent Contact CONSTANCE G BUNDY
Regulation Number876.1500
Classification Product Code
FEB  
Date Received09/16/1991
Decision Date 02/22/1994
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
Recalls CDRH Recalls
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