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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 K994381
Device Name PROSPORE2 SELF-CONTAINED BIOLOGICAL INDICATOR
Applicant
Raven Biological Laboratories, Inc.
8607 Park Dr.
Omaha,  NE  68127
Applicant Contact WENDY ROYALTY
Correspondent
Raven Biological Laboratories, Inc.
8607 Park Dr.
Omaha,  NE  68127
Correspondent Contact WENDY ROYALTY
Regulation Number880.2800
Classification Product Code
FRC  
Date Received12/28/1999
Decision Date 03/30/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Expedited Review Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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