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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector, Fluid, Non-Electrically Powered
510(k) Number K905062
Device Name INJECTOR, INSULIN
Applicant
Sound 2000 Medical Systems, Inc.
7450 France Ave., S.
Edina,  MN  55435
Applicant Contact WALKER
Correspondent
Sound 2000 Medical Systems, Inc.
7450 France Ave., S.
Edina,  MN  55435
Correspondent Contact WALKER
Regulation Number880.5430
Classification Product Code
KZE  
Date Received11/09/1990
Decision Date 03/15/1991
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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