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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 K991575
Device Name PRIMUS STEAM STERILIZERS
Applicant
Primus Sterilizer Co., Inc.
117 S. 25th St.
Omaha,  NE  68131
Applicant Contact JEFF REED
Correspondent
Primus Sterilizer Co., Inc.
117 S. 25th St.
Omaha,  NE  68131
Correspondent Contact JEFF REED
Regulation Number880.6880
Classification Product Code
FLE  
Date Received05/06/1999
Decision Date 12/03/1999
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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