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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Ion Specific, Sodium
510(k) Number K910305
Device Name GEM-PREMIER SYSTEM
Applicant
Mallinckrodt Sensor Systems, Inc.
1230 Eisenhower Pl.
Ann Arbor,  MI  48108
Applicant Contact BRUCE M BURGESS
Correspondent
Mallinckrodt Sensor Systems, Inc.
1230 Eisenhower Pl.
Ann Arbor,  MI  48108
Correspondent Contact BRUCE M BURGESS
Regulation Number862.1665
Classification Product Code
JGS  
Date Received01/24/1991
Decision Date 04/03/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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