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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilizer, Steam
510(k) Number K233132
Device Name PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)
Applicant
Primus Sterilizer Company, LLC
7936 Forest City Rd., Suite 100
Orlando,  FL  32810
Applicant Contact Patrick Hansen
Correspondent
IZiel Healthcare
Pentagon P1, Office # 601 And 604 Magarpatta City
Hadapsar
Pune,  IN 411028
Correspondent Contact Ankur Naik
Regulation Number880.6880
Classification Product Code
FLE  
Date Received09/27/2023
Decision Date 12/19/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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