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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 K082817
Device Name PRIMUS STEAM STERILIZER, MODELS PSS5-G-1 AND PSS5-M
Applicant
Primus Sterilizer Company, LLC
5520 10th St.
Great Bend,  KS  67530
Applicant Contact LYLE LOHRMEYER
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number880.6880
Classification Product Code
FLE  
Date Received09/25/2008
Decision Date 05/21/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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