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510(k) K151597

Family of Steam Sterilizers B 28 series by Cefla S.C. — Product Code FLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 2016
Date Received
June 12, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilizer, Steam
Device Class
Class II
Regulation Number
880.6880
Review Panel
HO
Submission Type

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