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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 K926185
Device Name PRIMUS PSS SERIES STERILIZERS
Applicant
Primus Sterilizer Co., Inc.
4256 Redman Ave.
Omaha,  NE  68111
Applicant Contact ROBERTY M LACHOWEIZ
Correspondent
Primus Sterilizer Co., Inc.
4256 Redman Ave.
Omaha,  NE  68111
Correspondent Contact ROBERTY M LACHOWEIZ
Regulation Number880.6880
Classification Product Code
FLE  
Date Received12/08/1992
Decision Date 05/09/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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