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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 K981054
Device Name BROWNE GA INDICATOR FOR CIDEX PRODUCTS
Applicant
Albert Browne , Ltd.
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact CYNTHIA J M NOLTE, PH.D
Correspondent
Albert Browne , Ltd.
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact CYNTHIA J M NOLTE, PH.D
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received03/23/1998
Decision Date 12/07/1998
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
Recalls CDRH Recalls
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