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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator, Physical/Chemical Sterilization Process
510(k) Number K012335
Device Name BROWNE METREX 1.8% GLUTARALDEHYDE INDICATOR FOR METRICIDE 28 AND METRICIDE PLUS 30 SOLUTIONS
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
JOJ  
Date Received07/24/2001
Decision Date 10/01/2001
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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