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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K071433
Device Name SMS GLUCOSE CONTROL, MODEL 2120059
Applicant
Specialty Medical Supplies
940 Crossroads Blvd.
Seguin,  TX  78155
Applicant Contact JOHN C GORMLEY
Correspondent
Specialty Medical Supplies
940 Crossroads Blvd.
Seguin,  TX  78155
Correspondent Contact JOHN C GORMLEY
Regulation Number862.1660
Classification Product Code
JJY  
Date Received05/23/2007
Decision Date 06/28/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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