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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 K991294
Device Name MODIFICATION TO MEDI-JECT CORPORATION MEDI-JECTOR CHOICE NEEDLE-FREE INSULIN DELIVERY SYSTEM
Applicant
MEDI-JECT CORP.
161 CHESHIRE LANE, SUITE 100
MINNEAPOLIS,  MN  55441
Applicant Contact PEGGY L HOLLAND
Correspondent
MEDI-JECT CORP.
161 CHESHIRE LANE, SUITE 100
MINNEAPOLIS,  MN  55441
Correspondent Contact PEGGY L HOLLAND
Regulation Number880.5430
Classification Product Code
KZE  
Date Received04/15/1999
Decision Date 04/23/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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