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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name sterilizer, steam
510(k) Number K111736
Device Name TUTTNAUER EZ PLUS SERIES ELECTRONIC TABLETOP AUTOCLAVES
Applicant
TUTTNAUER CO. LTD.
1700 K STREET NW
SUITE 300
washington,  DC  20006
Applicant Contact theodore sullivan
Correspondent
TUTTNAUER CO. LTD.
1700 K STREET NW
SUITE 300
washington,  DC  20006
Correspondent Contact theodore sullivan
Regulation Number880.6880
Classification Product Code
FLE  
Date Received06/20/2011
Decision Date 12/08/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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