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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 K960790
Device Name PROSPORE II
Applicant
RAVEN BIOLOGICAL LABORATORIES, INC.
5017 LEAVENWORTH ST.
OMAHA,  NE  68106
Applicant Contact ROBERT DWYER
Correspondent
RAVEN BIOLOGICAL LABORATORIES, INC.
5017 LEAVENWORTH ST.
OMAHA,  NE  68106
Correspondent Contact ROBERT DWYER
Regulation Number880.2800
Classification Product Code
FRC  
Date Received02/26/1996
Decision Date 08/16/1996
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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