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510(k) K214057

STATIM 6000B Vacuum Autoclave by Scican , Ltd. — Product Code FLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 2022
Date Received
December 27, 2021
Clearance Type
Abbreviated
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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  • K072466 — STATIM 7000 (WITHOUT USB PORT), MODEL 01-702100, STATIM 7000 (WITH USB PORT), MO (December 19, 2007)

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