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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 K013256
Device Name BI-3M NEEDLE-FREE INJECTOR SYSTEM
Applicant
Felton International, Inc.
8210 Marshall Dr.
Lenexa,  KS  66214
Applicant Contact ALAN FELTON
Correspondent
Felton International, Inc.
8210 Marshall Dr.
Lenexa,  KS  66214
Correspondent Contact ALAN FELTON
Regulation Number880.5430
Classification Product Code
KZE  
Date Received10/01/2001
Decision Date 12/07/2001
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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