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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 K861582
Device Name INJET-100, FLUID INJECTOR
Applicant
Injet Medical Products, Inc.
22500 Muirlands Blvd.
Lake Forest,  CA  92630
Applicant Contact BOOHER, PH.D.
Correspondent
Injet Medical Products, Inc.
22500 Muirlands Blvd.
Lake Forest,  CA  92630
Correspondent Contact BOOHER, PH.D.
Regulation Number880.5430
Classification Product Code
KZE  
Date Received04/29/1986
Decision Date 02/03/1987
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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