DSD-91(TM) DISINFECTOR FOR FLEXIBLE ENDOSCOPES

Accessories, Cleaning, For Endoscope

MEDIVATORS, INC.

The following data is part of a premarket notification filed by Medivators, Inc. with the FDA for Dsd-91(tm) Disinfector For Flexible Endoscopes.

Pre-market Notification Details

Device IDK914145
510k NumberK914145
Device Name:DSD-91(TM) DISINFECTOR FOR FLEXIBLE ENDOSCOPES
ClassificationAccessories, Cleaning, For Endoscope
Applicant MEDIVATORS, INC. C/O C. G. BUNDY ASSOCIATES 6470 RIVERVIEW TERRACE Minneapolis,  MN  55432
ContactConstance G Bundy
CorrespondentConstance G Bundy
MEDIVATORS, INC. C/O C. G. BUNDY ASSOCIATES 6470 RIVERVIEW TERRACE Minneapolis,  MN  55432
Product CodeFEB  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-09-16
Decision Date1994-02-22

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04961333242887 K914145 000
04961333242870 K914145 000
04961333242863 K914145 000
00677964035647 K914145 000
00677964033858 K914145 000

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