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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 K222608
Device Name Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS
Applicant
Tuttnauer LTD.
Har-Tuv Industrial Zone
Beit-Shemesh,  IL 9910101
Applicant Contact Robert Basile
Correspondent
Tuttnauer LTD.
Har-Tuv Industrial Zone
Beit-Shemesh,  IL 9910101
Correspondent Contact Robert Basile
Regulation Number880.6880
Classification Product Code
FLE  
Date Received08/29/2022
Decision Date 12/16/2022
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
Predetermined Change
Control Plan Authorized		 No
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