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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 K093333
Device Name PRIMUS STEAM STERILIZER PSS8-AA (16X16X26 MULTI FUNCTIONAL STERILIZER), LAB/LO STERILIZER,PRIMUS STEAM STERILIZER PSS8
Applicant
Primus Sterilizer Company, LLC
117 S. 25th St.
Omaha,  NE  68131
Applicant Contact CONNIE MANSFIELD
Correspondent
Primus Sterilizer Company, LLC
117 S. 25th St.
Omaha,  NE  68131
Correspondent Contact CONNIE MANSFIELD
Regulation Number880.6880
Classification Product Code
FLE  
Date Received10/26/2009
Decision Date 04/02/2010
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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