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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 K991709
Device Name BROWNE CIDEX OPA 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
JOJ  
Date Received05/19/1999
Decision Date 10/08/1999
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
Recalls CDRH Recalls
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