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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 K051056
Device Name VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR
Applicant
ALBERT BROWNE LTD.
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Applicant Contact CYNTHIA J M. NOLTE
Correspondent
ALBERT BROWNE LTD.
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Correspondent Contact CYNTHIA J M. NOLTE
Regulation Number880.2800
Classification Product Code
FRC  
Date Received04/26/2005
Decision Date 10/20/2005
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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