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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 K041386
Device Name RAVEN PROTEST - STEAM
Applicant
RAVEN BIOLOGICAL LABORATORIES, INC.
8607 PARK DR.
OMAHA,  NE  68127
Applicant Contact WENDY ROYALTY-HANN
Correspondent
RAVEN BIOLOGICAL LABORATORIES, INC.
8607 PARK DR.
OMAHA,  NE  68127
Correspondent Contact WENDY ROYALTY-HANN
Regulation Number880.2800
Classification Product Code
FRC  
Date Received05/25/2004
Decision Date 08/09/2004
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
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