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510(k) K233132

PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB) by Primus Sterilizer Company, LLC — Product Code FLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2023
Date Received
September 27, 2023
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

Other clearances by Primus Sterilizer Company, LLC

  • K221474 — PRIMUS Healthcare Sterilizer (Model PSS11-HC) (February 10, 2023)
  • K093333 — PRIMUS STEAM STERILIZER PSS8-AA (16X16X26 MULTI FUNCTIONAL STERILIZER), LAB/LO S (April 2, 2010)
  • K082817 — PRIMUS STEAM STERILIZER, MODELS PSS5-G-1 AND PSS5-M (May 21, 2009)

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