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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Syringe Needle
510(k) Number K862325
Device Name THE INJECTOR
Applicant
American Medical Innovations, Inc.
611 Elliff
Neosho,  MO  64850
Applicant Contact GILBERT L GARROW
Correspondent
American Medical Innovations, Inc.
611 Elliff
Neosho,  MO  64850
Correspondent Contact GILBERT L GARROW
Regulation Number880.6920
Classification Product Code
KZH  
Date Received06/19/1986
Decision Date 02/27/1987
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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