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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion
510(k) Number K926191
Device Name SIGMA 7000 AND SIGMA70002
Applicant
Sigma
11020 W. Center St. Ext
Medina,  NY  14103
Applicant Contact CHARLES MARTINA
Correspondent
Sigma
11020 W. Center St. Ext
Medina,  NY  14103
Correspondent Contact CHARLES MARTINA
Regulation Number880.5725
Classification Product Code
FRN  
Date Received12/09/1992
Decision Date 08/31/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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