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510(k) K161848

Family of Steam sterilizers B17 B22 Series by Cefla S.C. — Product Code FLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2017
Date Received
July 5, 2016
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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