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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 K151597
Device Name Family of Steam Sterilizers B 28 series
Applicant
Cefla S.C.
Via Selice Provinciale 23/A
Imola (Bo),  IT 40026
Applicant Contact SILVIA SANSAVINI
Correspondent
Isemed S.R.L.
Via A. Bonetti 3/A
Imola,  IT 40026
Correspondent Contact MAURIZIO PANTALEONI
Regulation Number880.6880
Classification Product Code
FLE  
Date Received06/12/2015
Decision Date 03/04/2016
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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