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510(k) K192910

STATClave G4 Chamber Autoclave by Scican , Ltd. — Product Code FLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 2020
Date Received
October 15, 2019
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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  • K090265 — BRAVO AUTOCLAVE, MODELS 17, 17V AND 21V (May 15, 2009)
  • K073319 — STATMATIC 31 HANDPIECE MAINTENANCE UNIT (February 4, 2008)
  • K072466 — STATIM 7000 (WITHOUT USB PORT), MODEL 01-702100, STATIM 7000 (WITH USB PORT), MO (December 19, 2007)

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