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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 K913018
Device Name MED-E-JET INJECTOR
Applicant
Med-E-Jet D
12900 Triskett Rd.
Cleveland,  OH  44111
Applicant Contact JOHN J SIBISAN
Correspondent
Med-E-Jet D
12900 Triskett Rd.
Cleveland,  OH  44111
Correspondent Contact JOHN J SIBISAN
Regulation Number880.5430
Classification Product Code
KZE  
Date Received07/09/1991
Decision Date 09/16/1991
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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