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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 K962956
Device Name MEDI-JECTOR CHOICE NEEDLE-FREE INSULIN DELIVERY SYSTEM
Applicant
Medi-Ject Corp.
1840 Berkshire Ln.
North Plymouth,  MN  55441
Applicant Contact PETER L SADOWSKI
Correspondent
Medi-Ject Corp.
1840 Berkshire Ln.
North Plymouth,  MN  55441
Correspondent Contact PETER L SADOWSKI
Regulation Number880.5430
Classification Product Code
KZE  
Date Received07/30/1996
Decision Date 10/07/1996
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
Predetermined Change
Control Plan Authorized		 No
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