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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 K024079
Device Name ALIBI BIOLOGICAL INDICATOR, MODEL WS
Applicant
ARDEN LABORATORIES, INCORPORATED
468B STILLWATER RD.
WILLERNIE,  MN  55090 -0687
Applicant Contact ANGELEA STRANTZ
Correspondent
ARDEN LABORATORIES, INCORPORATED
468B STILLWATER RD.
WILLERNIE,  MN  55090 -0687
Correspondent Contact ANGELEA STRANTZ
Regulation Number880.2800
Classification Product Code
FRC  
Date Received12/10/2002
Decision Date 02/27/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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