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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 K122774
Model ASSV-AH06; ASSV-AH06E
Device Name SAKURA STEAM STERILIZAER MODEL ASSV-AH06; SAKURA STEAM STERILIZER MODEL ASSV-AH06E; SKYTRON INTEGRITY 175; SKYTRON INTEG
Original Applicant
SAKURA SEIKI CO., LTD.
46-1, shinden
chikuma, nagano,  JA 387-0018
Original Contact maria griffin
Regulation Number880.6880
Classification Product Code
FLE  
Date Received09/10/2012
Decision Date 05/09/2013
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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