SAKURA STEAM STERILIZAER MODEL ASSV-AH06; SAKURA STEAM STERILIZER MODEL ASSV-AH06E; SKYTRON INTEGRITY 175; SKYTRON INTEG

Sterilizer, Steam

SAKURA SEIKI CO., LTD.

The following data is part of a premarket notification filed by Sakura Seiki Co., Ltd. with the FDA for Sakura Steam Sterilizaer Model Assv-ah06; Sakura Steam Sterilizer Model Assv-ah06e; Skytron Integrity 175; Skytron Integ.

Pre-market Notification Details

Device IDK122774
510k NumberK122774
Device Name:SAKURA STEAM STERILIZAER MODEL ASSV-AH06; SAKURA STEAM STERILIZER MODEL ASSV-AH06E; SKYTRON INTEGRITY 175; SKYTRON INTEG
ClassificationSterilizer, Steam
Applicant SAKURA SEIKI CO., LTD. 46-1, SHINDEN Chikuma, Nagano,  JP 387-0018
ContactMaria Griffin
Product CodeFLE  
CFR Regulation Number880.6880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2012-09-10
Decision Date2013-05-09
Summary:summary

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