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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator, Biological Sterilization Process
510(k) Number K962441
Device Name PROSPORE(STEARO FOR STEAM STERILIZER)
Applicant
Raven Biological Laboratories, Inc.
P.O. Box 6408
5017 Leavenworth St.
Omaha,  NE  68106
Applicant Contact KERRIE GROFF
Correspondent
Raven Biological Laboratories, Inc.
P.O. Box 6408
5017 Leavenworth St.
Omaha,  NE  68106
Correspondent Contact KERRIE GROFF
Regulation Number880.2800
Classification Product Code
FRC  
Date Received06/24/1996
Decision Date 09/18/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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