FDA 510(k) Application Details - K962441

Device Classification Name Indicator, Biological Sterilization Process

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510(K) Number K962441
Device Name Indicator, Biological Sterilization Process
Applicant RAVEN BIOLOGICAL LABORATORIES, INC.
P.O. BOX 6408
5017 LEAVENWORTH ST.
OMAHA, NE 68106 US
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Contact KERRIE GROFF
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Regulation Number 880.2800

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Classification Product Code FRC
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Date Received 06/24/1996
Decision Date 09/18/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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