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510(k) K112872

STATIM 2000 G4 CASSETTE by Scican , Ltd. — Product Code FLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 2012
Date Received
September 30, 2011
Clearance Type
Special
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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