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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 K120149
Device Name SKYRON INTEGRITY 215 STEAM STERILIZER SKYTRON INTEGRITY 215 SG STEAM STERILIZER SAKURA STEAM STERILIZER ASSV-AB09 SAKURA
Applicant
Sakura Seiki Co., Ltd.
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Applicant Contact MARIA F GRIFFIN
Correspondent
Tuv Sud America, Inc.
1775 Old Highway 8 NW
New Brighton,  MN  55112 -1891
Correspondent Contact DAWN TIBODEAU
Regulation Number880.6880
Classification Product Code
FLE  
Date Received01/18/2012
Decision Date 05/08/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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